FDA Adverse Event
Injury
Summary report: N
ACRYSOF RESTOR IOL
MDR report key: 5780623
·
Received July 9, 2016
Report
- Report Number
- 1119421-2016-01005
- Event Type
- Injury
- Date Received
- July 9, 2016
- Report Date
- February 1, 2017
- Manufacturer
- ALCON RESEARCH, LTD. - HUNTINGTON
- Product Code
- MFK
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT EXPERIENCED HALOS.
Description of Event or Problem · 1
A DOCTOR REPORTED THAT A PATIENT COULD NOT READ FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. YAG LASER WAS PERFORMED REGARDING SLIGHT POSTERIOR CAPSULAR OPACITY (PCO) ON AN UNKNOWN DATE. A SMALL RESIDUAL REFRACTION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434315 | ACRYSOF RESTOR IOL | LENS, MULTIFOCAL INTRAOCULAR | MFK | ALCON RESEARCH, LTD. - HUNTINGTON | ASKU | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |