FDA Adverse Event
Other
Summary report: N
UKN -- IOL
MDR report key: 1821649
·
Received August 18, 2010
Report
- Report Number
- 1119421-2010-00902
- Event Type
- Other
- Date Received
- August 18, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 19, 2010
- 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
- FL, 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 REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 07/19/2010, 07/20/2010, 07/21/2010, 07/26/2010, AND 08/12/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).
Description of Event or Problem · 1
ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE INFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UKN -- IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. / HUNTINGTON | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |