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 2020-03-19 for IMPLANTABLE COLLAMER LENS (ICL) VICM5 13.7 N/A manufactured by Staar Surgical Company.
[184308118]
This product is not marketed in the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184308119]
The reporter indicated that a 13. 7mm, vicm5 13. 7, -06. 50 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019. Significant reduction of irido-corneal angels and excessive vault were observed, the lens was removed and exchanged for a shorter length lens on (b)(6) 2020 and the problem was resolved. Cause of the event is reported as sizing error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00501 |
| MDR Report Key | 9855370 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-10-21 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-06-07 |
| Date Added to Maude | 2020-03-19 |
| 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 INTRAOCULAR LENS |
| Product Code | MTA |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-16 |
| Model Number | VICM5 13.7 |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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 | 2020-03-19 |