iSymm Intraocular Lens FY-60AD (yellow), +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 04547480203171), received between Aug 3, 2016 and Aug 3, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Material Deformation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2016Crack; Material Deformation
REPORT STATED THAT THE SURGEON HAD TO ENLARGE THE INCISION TO EXPLANT THE IOL FROM THE PATIENT'S EYE. ANOTHER HOYA IOL WAS IMPLANTED AND THE PATIENT'S PROGNOSIS WAS REPORTED AS GOOD ON DAY OF EVENT ((B)(6) 2016) . ON THE POST EVENT FOLLOW-UP VISIT - ((B)(6) 2016), THE DOCTOR REPORTED PATIENT'S CONDITION WORSENED. CUSTOMER REPORTS THE MALFUNCTION AS A "CRACKED OR DEFORMED CARTRIDGE TIP SPLITTING AND LENS CRACKING DURING IOL INSERTION.
Patient problems: No Code Available
MAUDE report 5843441 ↗
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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