FDA Adverse Event
Malfunction
Summary report: N
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
MDR report key: 2081884
·
Received April 5, 2011
Report
- Report Number
- 2023826-2011-00287
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 11, 2011
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P900048
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (B)(4).
Description of Event or Problem · 1
THE RPTR STATED THE AQ2003V SILICONE THREE PIECE LENS WAS DAMAGED DURING LOADING, HOWEVER, IT WAS NOT DISCOVERED UNTIL AFTER IT WAS INSERTED INTO THE EYE. THE LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED WITHOUT ANY PT INJURY. THE RPTR INDICATED THEY WERE TRAINING A NEW TECH AND THE INCIDENT WAS A RESULT OF A LOADING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | AQ2003V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | STAARVISC II: LOT NUMBER UNKNOWN| AQ CARTRIDGE-FP: MODEL, LOT NUMBER UNKNOWN| INJECTOR: MODEL MSI-TM, LOT NUMBER UNKNOWN |