FDA Adverse Event
Injury
Summary report: N
EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
MDR report key: 23961674
·
Received January 5, 2026
Report
- Report Number
- 2023826-2026-00007
- Event Type
- Injury
- Date Received
- January 5, 2026
- Report Date
- January 5, 2026
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORNEAL EDEMA IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM# (B)(4).
Description of Event or Problem · 0
AN ARTICLE TITLED "A STUDY OF EFFICACY, SAFETY AND VISUAL OUTCOME OF TORIC IMPLANTABLE COLLAMER LENS IMPLANTATION FOR PATIENTS WITH MYOPIC ASTIGMATISM" ABOUT CORNEAL EDEMA, IRITIS, ELEVATED IOP. MEDICAL MANAGEMENT REQUIRED. CAUSE OF THE EVENT WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27974 | EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |