Optimum Extra roflufocon DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00865576000201), received between Jan 18, 2022 and Jan 18, 2022 — classified as 1 injury.

3 FDA recall records name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K033594, K160859, K161100, K180616); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 10, 2025Completed

   Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

   Z-2190-2025 · Root cause: Process control · FDA record ↗

2. Jun 10, 2025Completed

   Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

   Z-2191-2025 · Root cause: Process control · FDA record ↗

3. Jul 3, 2018Terminated

   Vials labeled for the prescriptions contained incorrect lenses

   Z-2981-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A SUBJECT IN A CLINICAL STUDY FOR THE ONEFIT MED SCLERAL LENS MANUFACTURED FROM THE OPTIMUM EXTRA RGP MATERIAL. THE PATIENT WORE THE LENS FOR 45 MINUTES ON THE MORNING OF (B)(6) 2021 AFTER WHICH THE PATIENT WORE THEIR DAILY DISPOSABLE SOFT CONTACT LENS. ONSET OF HALOES VISION WAS NOTICED ON THE MORNING OF (B)(6) 2021 AND THE DAILY DISPOSABLE SOFT LENSES WERE DISCONTINUED. THE PATIENT WAS PRESENTED AT (B)(6) CLINIC ON (B)(6) 2021 WHERE A CORNEAL ULCER OF ~1- 1.5MM IN SIZE AND MILD IRITIS WERE DIAGNOSED. THE PATIENT WAS TREATED WITH ANTIBIOTIC EYE DROP AND OINTMENT. AS OF (B)(6) 2021 THE ADVERSE EVENT WAS RESOLVED AND PATIENT'S CORNEAL HEALTH IS NOW FINE.

  Patient problems: Corneal Ulcer; Halo; Iritis

  MAUDE report 13285885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033594, K160859, K161100, K180616. One submission often covers many models, so check the product and lot details in each record.

• Z-2982-2018 · Jul 3, 2018 · Terminated
  Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog N