FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 8028305
·
Received November 1, 2018
Report
- Report Number
- 2023826-2018-01589
- Event Type
- Injury
- Date Received
- November 1, 2018
- Date of Event
- December 11, 2017
- Report Date
- October 3, 2018
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: THIS IS A DUPLICATE FILE OF MDR # 2023826-2018-00125. PLEASE REFER TO MDR # 2023826-2018-00125 FOR FURTHER DETAILS. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT A 13.2MM, VTICMO13.2, -8.5/+1.0/92 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2017 THE LENS WAS REMOVED AND REPLACED FOR A SHORTER LENGTH LENS DUE TO OBSERVATION OF EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870057 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VTICMO13.2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |