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.
[183917240]
The reporter has indicated the injector is not available for return. The investigation is in progress. A follow up report will be submitted as additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[183917241]
It was reported that during surgery, the surgeon noticed that the intraocular lens (iol) implanted into the left (os) eye, appeared to have a scratch on the optic. The lens was removed and replaced intraoperatively with an iol of the same model and diopter. The second iol implanted successfully. There was no damage to the capsular bag, no loss of vitreous. There was no vitrectomy and the plan of surgery did not change. However, the incision was enlarged in order to remove the lens and sutures were required. In the physician's opinion, the most likely cause of the iol damage was forceps/handling. The patient's current prognosis was blurry vision at 24hrs. At 48 hrs, vision was improving. The doctor has continued to monitor and the patient is doing very well and the vision has improved immensely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00044 |
| MDR Report Key | 9757805 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-03 |
| 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 | 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 |
| Catalog Number | BLIS-X1 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |