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 BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE BLIS-X1 manufactured by Bausch & Lomb.
[183917421]
According to the reporter the product is not available for analysis as it was discarded. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[183917422]
It was reported that during insertion of an intraocular lens (iol) into the right eye the haptic was broken. The lens was removed intraoperatively. The incision was enlarged from 2. 4mm to 2. 8mm in size to remove the iol. A second iol of the same model and diopter was successfully implanted. Sutures were placed as part of standard protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00046 |
| MDR Report Key | 9759204 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-28 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-23 |
| 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 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 | 2020-02-26 |
| 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 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 |