FDA Adverse Event
Injury
Summary report: N
POSTERIOR CHAMBER LENS
MDR report key: 1902120
·
Received November 10, 2010
Report
- Report Number
- 1119421-2010-01229
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 18, 2010
- Report Date
- October 11, 2010
- Manufacturer
- ALCON RESEARCH, LTD./HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P810032
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
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. ADD'L INFO WAS REQUESTED ON BY 10/11/2010 AND 10/29/2010 PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).
Description of Event or Problem · 1
A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS "IMPLANTED THEN EXPLANTED" AND A DIFFERENT MODEL LENS WAS USED INSTEAD. PT IMPACT REMAINS UNK. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSTERIOR CHAMBER LENS | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD./HUNTINGTON | MC70CM | 10837386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |