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 2019-05-22 for IMPLANTABLE COLLAMER LENS (ICL) VICM5 12.1 N/A manufactured by Staar Surgical Company.
[145777655]
This product is not marketed in the us. (b)(4). No similar complaint type events were reported for units within the same lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145777656]
The reporter indicated that on (b)(6) 2019 a 12. 1mm, vicm5 12. 1, -12. 50 diopter, implantable collamer lens, "was folded in half and did not open well. " reportedly the lens unfolded upside down in the eye, the lens tore during removal and the lens was exchanged on (b)(6) 2019, problem resolved. No patient injury. On 20/apr/2019 patient has corneal edema. Per the reporter on (b)(6) 2019, patient's "corneal edema is resolved. Patient is happy now. " cause of the event is reported as "the lens is too sticky and less space in acd to maneuver. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2019-00842 |
| MDR Report Key | 8632085 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-05-22 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-19 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2019-05-22 |
| 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 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer G1 | STAAR SURGICAL COMPANY |
| Manufacturer Street | 1911 WALKER AVENUE |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91016 |
| 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 | 2019-05-22 |
| Returned To Mfg | 2019-05-28 |
| Model Number | VICM5 12.1 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STAAR SURGICAL COMPANY |
| Manufacturer Address | 1911 WALKER AVENUE MONROVIA CA 91016 US 91016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-22 |