FDA Adverse Event
Malfunction
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 3081576
·
Received April 29, 2013
Report
- Report Number
- 2023826-2013-00325
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- January 18, 2013
- Report Date
- April 5, 2013
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED DRY. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. CLAIM # (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON NOTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS WAS TORN PRIOR TO LOADING. THERE WAS NO PATIENT CONTACT AND A NEW LENS WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184586 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | CARTRIDGE: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK |