FDA Adverse Event
Injury
Summary report: N
LIGHT ADJUSTABLE LENS (LAL)
MDR report key: 12606280
·
Received October 11, 2021
Report
- Report Number
- 3012712027-2021-00060
- Event Type
- Injury
- Date Received
- October 11, 2021
- Report Date
- October 8, 2021
- Manufacturer
- RXSIGHT, INC.
- Product Code
- PZK
- UDI-DI
- 00818806020180
- PMA / PMN Number
- P160055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
PATIENT REPORTED A CHANGE IN VISUAL ACUITY SEVERAL DAYS AFTER THE FIRST LOCKIN. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS WAS (B)(6) 2021. DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED. NO ISSUES WERE NOTED. VISUAL INSPECTION OF THE RETURNED LENS FOUND THE LENS HAD BEEN CUT INTO MULTIPLE FRAGMENTS. VISUAL INSPECTION AND OPTICAL TESTING OF THE LENS FOUND NO ISSUES WITH THE LENS.
Description of Event or Problem · 0
PATIENT REPORTED A CHANGE IN VISUAL ACUITY SEVERAL DAYS AFTER THE FIRST LOCKIN. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS WAS (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1502313 | LIGHT ADJUSTABLE LENS (LAL) | LIGHT ADJUSTABLE LENS (LAL), PRODUCT CODE: PZK | PZK | RXSIGHT, INC. | 60005 | L02-001828 | 00818806020180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |