MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-27 for IMPLANTABLE COLLAMER LENS (ICL) VTICMO13.2 N/A manufactured by Staar Surgical Company.
[189089490]
Pma/510k: this product is not marketed in the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189089491]
The reporter indicated that the surgeon implanted a 13. 2mm vticmo13. 2, -15. 00/2. 5/088 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2019. The lens was removed and replaced on (b)(6) 2019 for a shorter length lens due to excessive vault. This resolved the problem. Cause of the event is reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2023826-2020-00590 |
MDR Report Key | 9889374 |
Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
Date Received | 2020-03-27 |
Date of Report | 2020-03-03 |
Date of Event | 2019-02-25 |
Date Mfgr Received | 2020-03-03 |
Device Manufacturer Date | 2018-06-28 |
Date Added to Maude | 2020-03-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. CYNTHIA THAI |
Manufacturer Street | 1911 WALKER AVENUE |
Manufacturer City | MONROVIA, CA |
Manufacturer Country | US |
Manufacturer G1 | STAAR SURGICAL COMPANY |
Manufacturer Street | 1911 WALKER AVENUE |
Manufacturer City | MONROVIA, CA |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | IMPLANTABLE COLLAMER LENS (ICL) |
Generic Name | PHAKIC TORIC INTRAOCULAR LENS |
Product Code | QCB |
Date Received | 2020-03-27 |
Model Number | VTICMO13.2 |
Catalog Number | N/A |
Lot Number | N/A |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STAAR SURGICAL COMPANY |
Manufacturer Address | 1911 WALKER AVENUE MONROVIA, CA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-27 |