FDA Adverse Event
Malfunction
Summary report: N
SEE H-10
MDR report key: 4097336
·
Received September 17, 2014
Report
- Report Number
- 2023826-2014-00723
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 19, 2014
- Report Date
- August 21, 2014
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P880091
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE®). (B)(4) - NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT; TORN MATERIAL. (B)(4).
Additional Manufacturer Narrative · 1
THE LAF CARD WAS RECEIVED WITH THE PATIENT INFORMATION.(B)(4)
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT STAAR SENT THEM THE WRONG INJECTOR AND AS A RESULT A HAPTIC OF THE AQ5010V THREE PIECE SILICONE LENS TORE ON INSERTION. THE SURGEON CUT THE LENS AND REMOVED IT WITHOUT ANY PATIENT INJURY. THE LENS WAS DISCARDED. THE REPORTER STATED THE EVENT WAS DUE TO USING THE WRONG INJECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577164 | SEE H-10 | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | AQ5010V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |