MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for LASER PROBES 8065751593 manufactured by Alcon Research, Llc - Irvine Technology Center.
[138757979]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138757980]
A customer reported that during a procedure to repair a large retinal tear with a significant amount of lattice, in the left eye, the laser probe seemed to loose power and the light source and aiming beam became very dim. A second laser probe was used and there was difficulty getting a laser burn. The surgeon had to increase the laser output higher than he typically uses, as a result, a "pop" was heard and a large bubble was created. Once the bubble went away, it was observed that the laser burn had caused a focal destruction of the retina, rpe, and choroid so that the bare sclera was likely visible. There was no bleeding and the spot was fairly small and anterior. The surgeon was able to put normal burns around it. He continued to use the second probe, but then the light and aiming beam became dim. A third laser probe was used to complete the case without further incident. This is the first of two reports as it is unknown which lot was associated with the second probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2019-00417 |
| MDR Report Key | 8418896 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-10-02 |
| Device Manufacturer Date | 2018-08-02 |
| Date Added to Maude | 2019-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASER PROBES |
| Generic Name | INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED |
| Product Code | HQE |
| Date Received | 2019-03-13 |
| Model Number | NA |
| Catalog Number | 8065751593 |
| Lot Number | 18027758X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-13 |