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 2020-03-23 for IMPLANTABLE COLLAMER LENS (ICL) VICMO12.6 N/A manufactured by Staar Surgical Company.
[189087067]
Pma/510k: the product is manufactured in the us, but not marketed in the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189087068]
The reporter indicated the surgeon implanted a 12. 6mm vicmo12. 6 implantable collamer lens, diopter -5. 0 into the patient's right eye (od) on (b)(6) 2019. On (b)(6) 2019 the lens was explanted due to excessive vault. The cause of the event is reported as unknown. Reportedly the patient was not satisfied with "implanted effect, give up lens implantation. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00618 |
| MDR Report Key | 9869329 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-10-06 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2020-03-23 |
| 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 Phone | 2927902237 |
| 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 INTRAOCULAR LENS |
| Product Code | MTA |
| Date Received | 2020-03-23 |
| Model Number | VICMO12.6 |
| 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 | 2020-03-23 |