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.
[188881059]
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
[188881060]
The reporter indicated the surgeon implanted a 12. 6mm vicm5_12. 6 implantable collamer lens, -10. 50 diopter, in the patient's right eye (od), on (b)(6) 2019. The lens was explanted on (b)(6) 2019 due to patient discomfort (due to presbyopia). The lens was exchanged for a shorter lens and the problem was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00669 |
| MDR Report Key | 9881045 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-03-16 |
| 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 |