FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 9842714
·
Received March 17, 2020
Report
- Report Number
- 2023826-2020-00517
- Event Type
- Injury
- Date Received
- March 17, 2020
- Date of Event
- February 18, 2020
- Report Date
- February 24, 2020
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LG
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION: LENS WAS RETURNED IN A MICRO-CENTRIFUGE VIAL WITH MOISTURE ON THE LENS. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. CLAIM#: (B)(4).
Additional Manufacturer Narrative · 1
PMA/510K: THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VICM5_13.7 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT AND GLARE/HALOS. THE PROBLEM WAS RESOLVED HOWEVER, PATIENT'S CONDITION AT FINAL VISIT IS MARKED AS "MODERATE CORNEAL EDEMA." THE CAUSE OF THE EVENT IS REPORTED AS A PATIENT-RELATED FACTOR AND "ANATOMICAL." REFERENCE MFR FLE# (B)(4) FOR 2ND IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306610 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICM5_13.7 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention | CARTRIDGE MODEL-SFC-45, LOT#-1450351| FOAM TIP PLUNGER MODEL-FTP, LOT#-1449924 |