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 2020-03-24 for IMPLANTABLE COLLAMER LENS (ICL) VTICM5_13.2 N/A manufactured by Staar Surgical Company.
[189087244]
Pma/510k: this product is not marketed in the us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189087245]
The reporter indicated that a 13. 2mm, vticm5_13. 2, -11. 50/+2. 0/95 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020. Pigment dispersion, unreactive (fixed) pupil, blurred vision, iris atrophy, lens opacity asc and pupil block were observed. Secondary surgical intervention (yag and anterior chamber irrigation) and medical intervention (eye drops to reduce inflammation) were performed/prescribed. The reporter stated " the opacity was seen before ac irrigation and before yag pi. Patient iop is stable and va is improving. The doctor is waiting for pupil improvements since it seems to be slightly stuck to the icl. " patients last visit date (b)(6) 2020 ucva was reported to be 20/30, bcva pin-hole 20/25, asc opacity remains the same, in continues evaluation. If additional information is received a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2020-00634 |
| MDR Report Key | 9874226 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-12-31 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| 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 | 2020-03-24 |