FDA Adverse Event
Malfunction
Summary report: N
MICROSTAAR® INJECTOR
MDR report key: 3740998
·
Received April 11, 2014
Report
- Report Number
- 2023826-2014-00272
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- February 14, 2014
- Report Date
- March 13, 2014
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- KYB
- PMA / PMN Number
- K940593
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO LENS IN UNIT CARTON. THE LAF AND PATIENT INFORMATION CARDS WERE PROVIDED. (B)(4)
Additional Manufacturer Narrative · 1
EXPIRATION DATE: UNKNOWN (B)(4) - NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. DELIVERY SYSTEM FAILURE. (B)(4).
Description of Event or Problem · 1
THE AQ5010V THREE PIECE SILICONE LENS BOX WAS RECEIVED EMPTY AND A COMMENT ON THE LAF CARD STATED "MALFUNCTION OF THE SHOOTER." NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ANY ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224220 | MICROSTAAR® INJECTOR | INTRAOCULAR LENS GUIDE | KYB | STAAR SURGICAL COMPANY | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | LENS MODEL AQ5010V, SERIAL NUMBER (B)(4) |