MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for STELLARIS ELITE ADAPTIVE FLUIDICS MICS PREMIUM PACK BL5115-3 manufactured by Bausch + Lomb.
[186832519]
The device history was reviewed and found to meet manufacturing specifications. Additional information has been requested. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[186832520]
A user facility in (b)(6) reported a 1 cm long, white, rigid, and eyelash-shaped piece of plastic was found in the eye during surgery. According to the sales representative, the foreign material was too long to come from the tightening key. The foreign material was aspirated and removed from the eye without causing any damage to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00053 |
| MDR Report Key | 9899594 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | MRS. JULI MOORE |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLARIS ELITE ADAPTIVE FLUIDICS MICS PREMIUM PACK |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-30 |
| Model Number | BL5115-3 |
| Catalog Number | BL5115-3 |
| Lot Number | W5454 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-30 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |