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 2018-08-22 for 25GA ILLUMINATED DIRECTIONAL LASER PROBE 55.48.25P manufactured by Bausch + Lomb.
[117960793]
Report #1 of 2. The product was requested and the return is still pending.
Patient Sequence No: 1, Text Type: N, H10
[117960794]
A report from a user facility in the (b)(6) stated that on two occasions the laser probe was not firing in the correct place. Additional information received from the vigilance authorities in the (b)(6), stated that the laser probe was bending within the eye causing the laser beam to be misdirected to inappropriate section of the eye making the procedure more difficult and timely. There was no patient injury however the patient required prolonged anesthesia and additional shot of the laser beam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001932402-2018-00012 |
| MDR Report Key | 7806858 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-22 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-20 |
| Date Added to Maude | 2018-08-22 |
| 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 | JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SYNERGETICS INC |
| Manufacturer Street | 3845 CORPORATE CENTRE DRIVE |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25GA ILLUMINATED DIRECTIONAL LASER PROBE |
| Generic Name | SYNERGETIC ENDO-OCULAR LASER PROBE |
| Product Code | HQB |
| Date Received | 2018-08-22 |
| Model Number | 55.48.25P |
| Lot Number | M0014568 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N GOODMAN ST ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-22 |