MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-26 for CRYSTALSERT INSERTER CI-28 manufactured by Bausch + Lomb.
[183917594]
The delivery device has not been returned for evaluation. The investigation is on-going. A follow up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[183917595]
It was reported that upon insertion of the intraocular lens (iol) into the right (od) eye, the haptic tore away from the lens body. The iol damage was noticed intraoperatively and the iol was removed with lens cutters. The capsular bag was damaged and the surgery was aborted due to hemorrhage and a loss of vitreous. A vitrectomy was performed. The incision was not enlarged, but a suture of 10. 0 nylon was used. The plan of surgery changed and the patient was left aphakic with no secondary iol implanted until visual status has stabilized. Patient has been referred to a retina specialist with a plan for a 2? Anterior chamber (ac) lens later. The patient's prognosis is good. In the physician's opinion, the most likely cause of the iol damage was a defective lens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00047 |
| MDR Report Key | 9759334 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33759 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYSTALSERT INSERTER |
| Generic Name | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
| Product Code | MSS |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-03-04 |
| Model Number | CI-28 |
| Catalog Number | CI-28 |
| Lot Number | H963802 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |