FDA Adverse Event
Injury
Summary report: N
ACRYSOF IQ TORIC SINGLEPIECE IOL
MDR report key: 6184677
·
Received December 18, 2016
Report
- Report Number
- 9612169-2016-00166
- Event Type
- Injury
- Date Received
- December 18, 2016
- Report Date
- December 18, 2016
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- MJP
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE IOL MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).
Description of Event or Problem · 1
A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) THAT WAS EXCHANGED DUE TO GLARE. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835212 | ACRYSOF IQ TORIC SINGLEPIECE IOL | LENS, INTRAOCULAR, TORIC OPTICS | MJP | ALCON LABORATORIES IRELAND LTD. | SN6AT3 | 21143333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |