FDA Adverse Event
Malfunction
Summary report: N
SEE H-10
MDR report key: 4323959
·
Received December 11, 2014
Report
- Report Number
- 2023826-2014-01102
- Event Type
- Malfunction
- Date Received
- December 11, 2014
- Date of Event
- November 4, 2014
- Report Date
- November 18, 2014
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED A HAPTIC AND PIECES OF THE OPTIC WERE TORN OFF AND MISSING AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE DEVICE. THE LAF CARD WAS PROVIDED WITH PATIENT INFORMATION. (B)(4).
Additional Manufacturer Narrative · 1
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®).(B)(4)
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE AA4204VL SILICONE SINGLE PIECE LENS RIPPED AS IT WAS BEING INSERTED AND WAS REMOVED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE EVENT WAS THE RESULT OF A LOADING ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804532 | SEE H-10 | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | AA4204VL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | INJECTOR MODEL MSI-TR, LOT NUMBER UNKNOWN| CARTRIDGE MODEL MTC-60CFP, LOT NUMBER UNKNOWN |