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 2017-03-03 for INTREPID AUTOSERT IOL HANDPIECE 8065751755 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[69009999]
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
[69010000]
A surgeon reported that while implanting an intraocular lens (iol) the plunger of the injector overrode the lens and it broke while entering the capsular sac. The surgeon removed the iol and used an alternate iol.
Patient Sequence No: 1, Text Type: D, B5
[77944178]
No further information was able to be obtained from this customer. With no additional, related information provided, the customers reported event was not able to be confirmed. The system was manufactured on november 6, 2015. Based on qa assessment, the product met specifications at the time of release. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2017-00958 |
| MDR Report Key | 6376355 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-03 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-05-23 |
| Date Added to Maude | 2017-03-03 |
| 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. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - 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 | 2017-03-03 |
| Model Number | NA |
| Catalog Number | 8065751755 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-03 |