FDA Adverse Event
Other
Summary report: N
UNK - IOL
MDR report key: 1318389
·
Received February 19, 2009
Report
- Report Number
- 1119421-2009-00128
- Event Type
- Other
- Date Received
- February 19, 2009
- Date of Event
- January 1, 2009
- Report Date
- January 20, 2009
- Manufacturer
- ALCON RESEARCH, LTD./ HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED, BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 02/01/2009 AND 02/18/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 02/19/2009.
Description of Event or Problem · 1
A SURGEON REPORTED HAVING A PT EXPERIENCING AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK - IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD./ HUNTINGTON | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |