iSymm Intraocular Lens FC-60AD (clear), +21.50DRecalls & 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 04547480104072), 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) THIS COMPLAINT) AND THE OTHER ON (B)(6) 2017 (SERIAL NUMBER (B)(4) SECOND, SEPARATE 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 11038495 ↗
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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