FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 15765123
·
Received November 9, 2022
Report
- Report Number
- 2023826-2022-03998
- Event Type
- Injury
- Date Received
- November 9, 2022
- Date of Event
- October 5, 2022
- Report Date
- October 13, 2022
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). CLAIM#: (B)(4).
Description of Event or Problem · 0
THE REPORTER STATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -10.50/1.0/089 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2022. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS REPORTED. THE LENS REMAINS IMPLANTED. STEROID EYE DROPS AND ORAL MEDICATION WERE PRESCRIBED. REPORTER STATES THE PROBLEM HAS NOT RESOLVED AND PATIENT OUTCOME STATUS IS UNKNOWN. CAUSE REPORTED AS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2328733 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | VTICM5 12.6 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention | CARTRIDGE MODEL-ACCUJET, LOT#-UNK| INJECTOR MODEL-ACCUJET, LOT#-UNK |