FDA Adverse Event
Malfunction
Summary report: N
UNK -- IOL
MDR report key: 1231084
·
Received October 30, 2008
Report
- Report Number
- 1119421-2008-00868
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Report Date
- September 30, 2008
- Manufacturer
- ALCON RESEARCH, LTD.
- Product Code
- HQL
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED 9/30/2008, 10/9/2008 AND 10/15/2008 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
A SURGEON REPORTS THAT AN IMPLANTED INTRAOCULAR LENS (IOL) IS "MOVING" IN A PT WITH A HISTORY OF A VITRECTOMY AND AN UNSTABLE IRIS. THE IS UNSURE WHETHER THE MOVEMENT IS A RESULT OF THE LENS LENGTH OR THE PT'S UNSTABLE IRIS. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK -- IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |