MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-05-23 for IMPLANTABLE COLLAMER LENS (ICL) VICMO 13.2 N/A manufactured by Staar Surgical Company.
[145971780]
This product is not marketed in the us. Lens was returned in a micro-centrifuge vial with moisture on lens. Visul inspection found that the haptic was torn and resence of residue on lens surface. (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
[145971781]
The reporter indicated that a 13. 2mm, vicmo 13. 2, 12. 50 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2018. A lens tear/break during injection/delivery into the eye was observed. There was patient contact but no patient injury. On (b)(6) 2019 the lens was removed and later replaced with another lens. It was reported that this replacement resolved the problem. In the reporters opinion the cause of this event was due to user error/ bad procedure of loading.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023826-2019-00895 |
| MDR Report Key | 8637361 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-05-23 |
| Date of Report | 2019-04-25 |
| Date of Event | 2018-12-30 |
| Date Mfgr Received | 2019-07-24 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2019-05-23 |
| 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 | 2019-05-23 |
| Returned To Mfg | 2019-04-30 |
| Model Number | VICMO 13.2 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2019-03-31 |
| 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 | 2019-05-23 |