MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-27 for MADLAB IRIS RETRACTOR E0750 NS manufactured by Bausch + Lomb.
[186832785]
Additional information has been requested. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[186832786]
A user facility in (b)(6) reported that, during the first appointment post-op, a little piece of the iris-hook was found by the surgeon via slit-lamp in the patient's cornea. The surgery was successful without any incident during the procedure. At this time, there is no patient injury. Therefore, the surgeon prefers to let the hook-piece stay in the cornea in order to not cause a lesion of the human tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00049 |
| MDR Report Key | 9892171 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-02 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-27 |
| 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 | MADLAB IRIS RETRACTOR |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-27 |
| Model Number | E0750 NS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |