FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 19075934
·
Received April 9, 2024
Report
- Report Number
- 2023826-2024-01594
- Event Type
- Injury
- Date Received
- April 9, 2024
- Report Date
- April 4, 2024
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- UDI-DI
- 00840311304714
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B5 - THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM512.1 -8.50/1.5/093 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON 21 DEC 2023. LOW VAULT WITH ROTATION WAS OBSERVED. LENS EXCHANGED WITH A LONGER LENGTH LENS ON 30 JAN 2024 AND PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. CLAIM# (B)(4).
Additional Manufacturer Narrative · 0
CLAIM# (B)(4).
Additional Manufacturer Narrative · 0
CLAIM#: (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM512.1 -8.50/150/100 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. LOW VAULT WAS OBSERVED. LENS EXCHANGED WITH A LONGER LENGTH LENS ON (B)(6) 2024 AND PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 511987 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICM5 12.1 | NA | 00840311304714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | FOAM TIP PLUNGER, LOT# 1652271.| MSI-PF, LOT# UNK.| SFC-45, LOT# 1642375. |