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 2020-03-25 for IMPLANTABLE COLLAMER LENS (ICL) VICM5_12.6 NA manufactured by Staar Surgical Company.
[189087646]
Pma/510k: this product is manufactured in the u. S. But not marketed in the u. S. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189087647]
The reporter indicated the surgeon implanted a 12. 6mm vicm5_12. 6 implantable collamer lens, -11. 50 diopter, in the patient's left eye (os), on (b)(6) 2020. The lens was explanted on (b)(6) 2020 due to low vaulting. The lens was exchanged for a longer lens and the problem was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00672 |
| MDR Report Key | 9880991 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-08-28 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3037902237 |
| 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 | 2020-03-25 |
| Returned To Mfg | 2020-03-18 |
| Model Number | VICM5_12.6 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-25 |