iSymm Intraocular Lens FC-60AD (clear), +22.50DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547480104096), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Blurred Vision1
- Eye Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DR. (B)(6) IMPLANTED BOTH LENSES. ONE LENS WAS IMPLANTED ON THE LEFT EYE ON (B)(6) 2017 (SERIAL NUMBER (B)(4) - PREVIOUS COMPLAINT) AND THE OTHER ON (B)(6) 2017 (SERIAL NUMBER (B)(4) - THIS COMPLAINT). IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED PRESSURE BEHIND THE EYE, HEADACHES, SENSITIVITY AND BLURRY VISION WHEN LOOKING AT A ITEMS AT A DISTANCE. PATIENT RETURNED TWICE TO HIS DOCTOR, THE DOCTOR TELLS HIM TO USE THE EYE DROPS. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 11038497 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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