FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 18965634
·
Received March 23, 2024
Report
- Report Number
- 2023826-2024-01249
- Event Type
- Malfunction
- Date Received
- March 23, 2024
- Report Date
- February 22, 2024
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS OF UNKNOWN MODEL WAS FOUND WITH A DEPOSIT OR DIRTY. IT IS UNKNOWN IF THE LENS HAD CONTACT WITH THE PATIENT AS NO FURTHER INFORMATION HAS BEEN RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1701042 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |