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) VTICMO13.7 NA manufactured by Staar Surgical Company.
[188882671]
This product is manufactured in the u. S. But not marketed in the u. S. (b)(4). No similar complaint was reported for units within the same lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188882672]
The reporter indicated the surgeon implanted a 13. 7mm vticmo13. 7 implantable collamer lens, -8. 5/+1. 5/084 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2019. The lens was explanted on (b)(6) 2019 due to patient experienced glare and halos. The lens was not exchanged for another lens. The cause of the event was due to patient related factor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00659 |
| MDR Report Key | 9881022 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-07-23 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-05-07 |
| 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 TORIC INTRAOCULAR LENS |
| Product Code | QCB |
| Date Received | 2020-03-25 |
| Model Number | VTICMO13.7 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |