FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 18725200
·
Received February 16, 2024
Report
- Report Number
- 2023826-2024-00657
- Event Type
- Injury
- Date Received
- February 16, 2024
- Report Date
- January 22, 2024
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- UDI-DI
- 00840311307807
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CLAIM # (B)(4).
Additional Manufacturer Narrative · 0
ADDITIONAL DATA: H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. CORRECTED DATA: D2: COMMON DEVICE NAME: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB CLAIM # (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THE SURGEON IMPLANTED AN ICL IMPLANTABLE COLLAMER LENS, INTO THE PATIENTS RIGHT EYE (OD). IT WAS REPORTED THE PATIENT EXPERIENCED ENDOTHELIAL CELL LOSS AND THE LENS REMAINED IMPLANTED. THE PATIENTS VISION IS EXCELLENT , WITH VERY SATISFACTORY REFRACTIVE OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425196 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICM5_12.6 | NA | 00840311307807 |
| 882039 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICM5_12.6 | NA | 00840311307807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |