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 2020-02-07 for BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE BLIS-X1 manufactured by Bausch + Lomb.
[178262533]
The reporter has indicated the device is not available for analysis. The investigation is ongoing. A follow up report will be submitted once additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[178262554]
It was reported that during insertion of an intraocular lens (iol) from another manufacturer using a bausch + lomb delivery device into the left eye (os), the surgeon noticed one of the iol haptics was not proper. The lens was removed intraoperatively, requiring enlargement of the 2. 2mm incision. The enlarged incision size was not provided. The procedure was not complicated in any way or combined with any other surgery. The orientation of the lens did not change and the optic was free and clear of imperfections. The patient did not notice a decrease in vision and no secondary surgical intervention was performed to treat the event. The capsular bag was not damaged, no sutures were required, and the patient is doing very well with no issues. In the surgeon's opinion, the likely cause of the event was a loading error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00031 |
| MDR Report Key | 9683137 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-10 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-04-01 |
| Date Added to Maude | 2020-02-07 |
| 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 N PARK PL BLVD |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246688 |
| 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 | 2020-02-07 |
| 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 NORTH GOODMAN ST ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-07 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |