A cluster of delayed postoperative intraocular inflammation cases involving fungal endophthalmitis has been reported among patients who underwent cataract surgery at a single facility between June 30 and August 6, 2026.
Clinical Presentation and Cluster Investigation Details
Reporting physicians note that several other patients presented with similar granulomatous postoperative inflammation patterns. These clinical presentations vary significantly in severity. According to the medical societies, many cases are subtle, showing only mild inflammation and reduced vision. More severe presentations include hypopyon, posterior capsular opacification, and vitreous snowballs.
Surgeons performed the procedures at a single facility involving multiple practitioners. Source investigations and microbiologic testing remain active. The reporting physicians identified exposure to a single common product among all identified patients: compounded moxifloxacin HCl 1 mg/mL preservative-free in balanced-salt solution for single-dose intracameral injection, specifically lot 2630398 supplied by Leiters Health. Physicians confirmed that no cases have appeared in patients at the same facility who did not receive the compounded medication from this specific lot.
Pro Tip: Vials from lot 2630398 are past their September 16, 2026 expiration date and are no longer expected to be in circulation. However, because fungal endophthalmitis often features a delayed presentation, clinicians should maintain vigilance for signs of inflammation appearing many weeks after surgery.
Manufacturer Response and Testing Results
Leiters Health stated that the flagged lot met all established batch-release specifications, which included sterility testing for both fungal and microbial agents, alongside endotoxin testing. Additional testing on retention units, including repeated USP sterility culture testing of retained units, produced sterile results according to the company.
Leiters Health distributed a total of 4,530 units to 57 facilities, including 100 units sent to the reporting facility. The company reported receiving no other product complaints or adverse event reports regarding this lot from the other 56 recipient facilities. Leiters Health notified the U.S. Food and Drug Administration (FDA) of the situation on August 21, 2026, with subsequent follow-up communications on September 4, September 10, and September 22.
Guidance for Clinicians and Case Identification
Due to the delayed and subtle presentation typical of fungal endophthalmitis, ASRS, ASCRS, and the Academy recommend specific steps for practicing physicians:
- Consider an infectious etiology in patients with unexplained, persistent, recurrent, or delayed inflammation following cataract surgery.
- Look specifically for findings such as keratic precipitates, hypopyon, vitreous inflammation or snowballs, and plaque or opacification involving the posterior capsule.
- Determine whether potentially affected patients received any shared products or surgical exposures.
- Preserve relevant microbiologic isolates and any remaining associated products for further potential testing in suspected clusters.
Did You Know? Fungal endophthalmitis following cataract surgery can present many weeks post-procedure, making retrospective reviews of lot numbers and shared surgical exposures critical for public health tracking.
Reporting Channels and Next Steps
ASRS, ASCRS, the Academy, and Leiters Health emphasize their commitment to sharing new information as it becomes available. Clinicians and facilities should report potentially related cases to Leiters Health at info@leiters.com, the ASRS ReST registry at ASRS.org/REST, the ASCRS TASS Task Force via tassregistry.org, and the FDA MedWatch program.
Frequently Asked Questions
What pathogen was identified in the affected patients?
Reporting physicians stated that Candida was grown from vitreous specimens collected from three of the affected patients.
Has the source of the fungal endophthalmitis cluster been confirmed?
No. The source of the reported infections remains undetermined, and contamination of any product or lot has not been demonstrated. Investigations by regulatory agencies and manufacturers remain ongoing.
Which lot of compounded medication is under scrutiny?
Physicians identified exposure to compounded moxifloxacin HCl 1 mg/mL preservative-free in balanced-salt solution for single-dose intracameral injection, lot 2630398, supplied by Leiters Health.
Where can physicians report suspected cases?
Physicians can report cases to Leiters Health, the ASRS ReST registry, the ASCRS TASS Task Force, and the FDA MedWatch reporting system.
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