FDA Adverse Event
Malfunction
Summary report: N
ACRYSOF MULTIPIECE IOL
MDR report key: 11331713
·
Received February 16, 2021
Report
- Report Number
- 1119421-2021-00321
- Event Type
- Malfunction
- Date Received
- February 16, 2021
- Report Date
- February 17, 2021
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE EVENT OCCURRED SOMETIME AROUND CHRISTMAS AND THAT THIS WAS A LOADING ISSUE BY A NEW SCRUB TECH DURING THE SURGERY. A NEW LENS WAS USED TO COMPLETE THE CASE.
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 1
A HEALTH PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANT WAS BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232758 | ACRYSOF MULTIPIECE IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LLC - HUNTINGTON | MA60AC | 15083129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |