FDA Adverse Event
Injury
Summary report: N
ACRYSOF IQ RESTOR SINGLEPIECE IOL
MDR report key: 8492105
·
Received April 8, 2019
Report
- Report Number
- 1119421-2019-00425
- Event Type
- Injury
- Date Received
- April 8, 2019
- Date of Event
- March 28, 2019
- Report Date
- April 8, 2019
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MFK
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 SIX (6) WEEKS AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT EXPERIENCED PAIN, REDNESS AND DECREASED VISION IN BOTH EYES. THIS RECORD IS FOR THE LEFT EYE. TREATMENT WAS PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286573 | ACRYSOF IQ RESTOR SINGLEPIECE IOL | LENS, MULTIFOCAL INTRAOCULAR | MFK | ALCON RESEARCH, LLC - HUNTINGTON | SV25T0 | 12521497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ATROPIN DROPS| DIPROPHOS 0.5| HYDROCORTISON IV| UNIDEXA DROPS| UNITROPIC DROPS| YELLOX DROPS |