MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-13 for BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE BLIS-X1 manufactured by Bausch + Lomb.
[183908164]
Though requested, no additional information has been received. The product was not returned for evaluation; consequently, no product evaluation was performed. A device history review could not be performed as no lot number has been provided. Based upon the complaint trend review, the volume of complaints is within the acceptable control limits and no complaint trend is observed. The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates. Proper loading of the intraocular lens (iol) in accordance with the directions for use is essential in facilitating the folding process of the iol. Incorrect loading can result in similar folding issues. In addition, the added viscoelastic (ovd) may also influence the folding of the iol. The iol may rub harder during advancing if too little viscoelastic is applied, or if zones of the loading chamber remain dry. Based on the current information, the root cause of the event could not be conclusively determined; however, user related factors, such as loading issues might have contributed to the event. No corrective action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[183908165]
It was reported that during the insertion of an intraocular lens (iol) there was a lens folding issue with the leading haptic. The incision was enlarged to remove the lens intraoperatively, and sutures were required. Though requested, no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00033 |
| MDR Report Key | 9707634 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-13 |
| Date of Report | 2019-10-23 |
| Date of Event | 2019-10-08 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-02-13 |
| 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 | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 N. PARK PLACE BLVD |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Manufacturer G1 | MEDICEL AG |
| Manufacturer Street | DORNIERSTRASSE 11 |
| Manufacturer City | ALTENRHEIN CH 9423 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE |
| Generic Name | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
| Product Code | MSS |
| Date Received | 2020-02-13 |
| Model Number | BLIS-X1 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-13 |