Optimum Infinite Tisilfocon ARecalls & reported problems
Contamac Holdings Limited · Rigid Gas Permeable Contact Lens · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jun 10, 2025Completed
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Z-2191-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jun 10, 2025Completed
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Z-2190-2025 · Root cause: Process control · Recall details · FDA record ↗
Other Lens, Contact (Other Material) - Daily devices
- Boston XO2 hexafocon BBausch & Lomb Incorporated · Lens, Contact (Other Material) - Daily3 recalls1 report
- Optimum Extra roflufocon DContamac Holdings Limited · Lens, Contact (Other Material) - Daily3 recalls1 report
- Optimum Extreme roflufocon EContamac Holdings Limited · Lens, Contact (Other Material) - Daily3 recalls0 reports
- Boston XO hexafocon ABausch & Lomb Incorporated · Lens, Contact (Other Material) - Daily2 recalls0 reports
- HEXA100 hexafocon AContamac Holdings Limited · Lens, Contact (Other Material) - Daily1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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