255
Report
- Report Number
- 3006723646-2024-00068
- Event Type
- Malfunction
- Date Received
- June 7, 2024
- Date of Event
- March 15, 2024
- Report Date
- June 7, 2024
- Manufacturer
- HOYA SURGICAL OPTICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P080004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THIS INITIAL AND FINAL EMDR REPORT IS BEING SUBMITTED TO THE FDA FOR AN EVENT THAT OCCURRED OUTSIDE THE USA. HAPTIC DAMAGE IS INDICATED AS A POTENTIAL MALFUNCTION RELATED TO THE IOL, AS STATED UNDER THE WARNINGS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: 255). FROM OUR INVESTIGATION, WE CONFIRMED THE REPORTED EVENT. THE EXACT ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND OUR INVESTIGATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY. CAPA-22-0009 HAS BEEN INITIATED FOR DAMAGED HAPTICS COMPLAINTS.
EVENT OCCURRED IN (B)(6). DAMAGED HAPTIC AFTER IMPLANTATION. THE TORN PMMA OF TRAILING HAPTIC HAS BEEN CONTINUED RECENTLY. THE PMMAS WERE REMOVED FROM THE EYES AND THE IOLS WAS REMAINED IN THE EYES. (THE DOCTOR THINK THERE IS NOT A PROBLEM WITH THE STABILITY.) OPERATED IT AS THE DESCRIPTIONS SUCH AS THE FIXING THE BODY AND THE SPEED OF THE SLIDER OPERATION AND SO ON BUT THE PROBLEM STILL OCCURRED. REQUIRED THE INVESTIGATION. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2318219 | 255 | INTRAOCULAR LENS | HQL | HOYA SURGICAL OPTICS, INC. | 255 (+ 20 D) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |