FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 14627814
·
Received June 7, 2022
Report
- Report Number
- 2023826-2022-01824
- Event Type
- Injury
- Date Received
- June 7, 2022
- Date of Event
- April 13, 2022
- Report Date
- May 11, 2022
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- UDI-DI
- 00841542108959
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CLAIM#: (B)(4).
Additional Manufacturer Narrative · 0
ADDITO NAL INFORMATION: B5 - IT WAS ADDITIONALLY LATER REPORTED THAT THE PATIENT ALSO EXPERIENCED BLURRED VISION AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND NOTED "SIZING". THE PROBLEM WAS RESOLVED. H6 - HEALTH EFFECT CLINICAL CODE: 4581 - SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLE. CLAIM#: (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -9.50/1.5/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS DUE TO HIGH VAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153621 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | TMICL13.2 | N/A | 00841542108959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male | Required Intervention | CARTRIDGE MODEL-SFC-45, LOT#-UNK.| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.| INJECTOR MODEL-MSI-PF, LOT#-UNK. |