FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 20263613
·
Received September 19, 2024
Report
- Report Number
- 2023826-2024-04346
- Event Type
- Injury
- Date Received
- September 19, 2024
- Report Date
- August 30, 2024
- Manufacturer
- STAAR SURGICAL
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURE NARRATIVE: SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM # (B)(4).
Description of Event or Problem · 0
A HEALTHCARE PROFESSIONAL REPORTED AN ARTICLE TITLED "CLINICAL OBSERVATIONS OF EVO-ICL IMPLANTATION WITH SINGLE INCISION WITHOUT VISCOELASTIC AGENT". THE ARTICLE STATES THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, PATIENT'S EXPERIENCED ELEVATED IOP. MEDICATION WAS ADMINISTERED FOR TREATMENT. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2335956 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL | UNK | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |