Boston XO2 hexafocon BRecalls & reported problems
Bausch & Lomb Incorporated · Rigid Gas Permeable Contact Lens · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00785811435677), received between Jan 8, 2024 and Jan 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
3 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.
Reports received per month
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 ↗
- Jul 3, 2018Terminated
Vials labeled for the prescriptions contained incorrect lenses
Z-2981-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Handling Problem1
Patient problems
- Corneal Abrasion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Device Handling Problem; Device Handling Problem
Other Lens, Contact (Other Material) - Daily devices
- 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
- Optimum Infinite Tisilfocon AContamac Holdings Limited · Lens, Contact (Other Material) - Daily2 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 · each report above links to its original FDA record
- 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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