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 2020-03-27 for IMPLANTABLE COLLAMER LENS (ICL) VTICM5_13.2 N/A manufactured by Staar Surgical Company.
[189089304]
Pma/510k: this product is not marketed in the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189089305]
The reporter indicated that the surgeon implanted a 13. 2mm vticm5_13. 5, -13. 00/5. 0/100 (sphere/cylinder/axis) , implantable collamer lens into the patient's right eye (od) on (b)(6) 2020. The lens was removed and replaced on (b)(6) 2020 for a longer length lens due to lens rotation and low vault. This resolved the problem. Cause of the event is reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00583 |
| MDR Report Key | 9889379 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-12-26 |
| Date Added to Maude | 2020-03-27 |
| 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 TORIC INTRAOCULAR LENS |
| Product Code | QCB |
| Date Received | 2020-03-27 |
| Model Number | VTICM5_13.2 |
| 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 | 2020-03-27 |