MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-25 for INTREPID AUTOSERT IOL HANDPIECE 8065751755 manufactured by Alcon Research, Llc - Irvine Technology Center.
[182178318]
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 the manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182178319]
A healthcare professional reported during laser assisted cataract surgery, the patient was uncooperative and the laser presented an error. Suction was attempted multiple times however, the digital marker did not recognize the crypts of the iris. There was no corneal opacity pattern. The laser enabled the secondary incision program and the arch use without command. The laser portion of the procedure was discontinued and the capsulotomy was completed manually without problems. Phacoemulsification was completed; however, during insertion of the lens with the intraocular handpiece, the intraocular lens ruptured the posterior capsule and entered the vitreous. A vitrectomy was performed and the lens was implanted in the ciliary sulcus. The surgeon indicated that the deltas were not checked or adjusted and indicated this occurred "due medical procedure, not due the equipment". The surgeon declined to provide further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00144 |
| MDR Report Key | 9752947 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-25 |
| 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 | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| 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 | INTREPID AUTOSERT IOL HANDPIECE |
| Generic Name | APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED |
| Product Code | HQR |
| Date Received | 2020-02-25 |
| Model Number | NA |
| Catalog Number | 8065751755 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-25 |