Optimum Extreme roflufocon ERecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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 ↗

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