FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 8129041
·
Received December 4, 2018
Report
- Report Number
- 2023826-2018-01773
- Event Type
- Injury
- Date Received
- December 4, 2018
- Date of Event
- November 9, 2018
- Report Date
- November 9, 2018
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- QCB
- UDI-DI
- 00841542109383
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UNK. (B)(4). LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 LENS, -12.5/+2.0/072 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT PRESENTED WITH BLURRY VISION, CORNEAL EDEMA, HIGH IOP AND EXCESSIVE VAULT. THE SURGEON PERFORMED A YAG PI AND PATIENT WAS PLACED ON IOP MEDICATIONS. CURRENTLY, THE PATIENT'S SYMPTOMS ARE RESOLVING AND VISION HAS IMPROVED. THE LENS REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 969860 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC TORIC INTRAOCULAR LENS | QCB | STAAR SURGICAL COMPANY | TMICL13.2 | NA | 00841542109383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |