FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 21390131
·
Received February 14, 2025
Report
- Report Number
- 2023826-2025-00259
- Event Type
- Injury
- Date Received
- February 14, 2025
- Report Date
- January 29, 2025
- 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
A4-A6: UNK. 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 "ROTATIONAL STABILITY AND OUTCOMES ODF V4C TORIC IMPLANTABLE COLLAMER LENSES PLACED AT DIFFERENT LENS ORIENTATIONS". THE ARTICLE STATES THERE WERE 22 CASES OF LENS ROTATION. 1 EYE WAS REPOSITIONED, AND 4 LENSES WERE REMOVED AND REPLACED. 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 |
|---|---|---|---|---|---|---|---|
| 1205384 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL | UNK | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |