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.
[186751122]
This product is not marketed in the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186751163]
The reporter indicated that the surgeon implanted a 13. 2mm vticm5_13. 5, -13. 00/4. 5/093 (sphere/cylinder/axis) , implantable collamer lens into the patient's left eye (os) 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. Cause of the event is reported as unknown. Additional information has been requested but none has been forthcoming. If additional information is received a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00582 |
| MDR Report Key | 9889364 |
| 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 | 2019-12-09 |
| 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 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 | 2020-03-27 |
| 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 |