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 2020-03-13 for STELLARIS MICRO INCISION VACUUM PACK BL5113 manufactured by Bausch + Lomb.
[183539493]
The manufacturing and sterilization records were reviewed and found to be acceptable. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[183539574]
The user facility in (b)(6) reported that during cataract procedure, a fragment of the tightening tool of the handpiece needle went into the patient? S eye. When the needle placed on the phaco device was inserted into the patient's eye the surgeon noticed a ''small piece of plastic. " the particulate was seen under the microscope and was removed using surgical pliers. The surgery time was not significantly increased. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00045 |
| MDR Report Key | 9830036 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-04 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-13 |
| 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 | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| 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 MICRO INCISION VACUUM PACK |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-11 |
| Model Number | BL5113 |
| Catalog Number | BL5113 |
| Lot Number | W4632 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |