FDA Adverse Event
Injury
Summary report: N
ACRSYOF
MDR report key: 1040485
·
Received May 9, 2008
Report
- Report Number
- 1119421-2008-00295
- Event Type
- Injury
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 9, 2008
- Manufacturer
- ALCON RESEARCH, LTD.
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 04/14/2008 AND 04/29/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE INTEGRITY OF THE CAPSULAR BAG WAS LOST. THE LENS WAS CUT OUT OF THE EYE AND REPLACED WITH A DIFFERENT MODEL. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRSYOF | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. | SN60WF | 10803876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |