FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 19879064
·
Received July 31, 2024
Report
- Report Number
- 2023826-2024-03441
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- June 24, 2024
- Report Date
- July 16, 2024
- Manufacturer
- STAAR SURGICAL
- Product Code
- QCB
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: G4- PREMARKET IDENTIFICATION: DEVICE BLA: P030016 TO PMA/510(K): P030016, INITIALLY REPORTED PMA/510(K) NUMBER IN THE WRONG FIELD. CLAIM # (B)(4).
Additional Manufacturer Narrative · 0
CLAIM # (B)(4).
Description of Event or Problem · 0
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY. CAUSE OF THE EVENT WAS REPORTS AS UNKNOWN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2250331 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL | VTICMO13.2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK| INJECTOR MODEL: MSI-TF, LOT# UNK |