MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-05-26 for INTREPID AUTOSERT IOL HANDPIECE 8065751755 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[5819176]
A customer reported that during cataract surgery, while the surgeon was advancing the intraocular lens (iol) using the autoinjector, the haptic of the iol was "ripped off. " the iol was removed through an enlarged incision and the same iol model and diopter power was implanted. Sutures were used to close the wound.
Patient Sequence No: 1, Text Type: D, B5
[13300504]
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
[27005162]
The customer reported that during cataract surgery, while the surgeon was advancing the intraocular lens (iol) using the auto-injector, the haptic of the iol was "ripped off. " the iol was removed through an enlarged incision and the same iol model and diopter power was implanted. Sutures were used to close the wound. The surgeon states the plunger is wider and more squared as opposed to the manual injector. The surgeon thinks this is why the iol was damaged. The surgeon is no longer using the injector handpiece (hp). The customer provided two handpiece serial numbers, however,the serial number of the handpiece used during this event was not recorded and remains unknown at this time. The auto-injector directions for use (dfu), includes recommendations on appropriate use. No information was received on which cartridge profile was selected. Both injector's were manufactured on september 15, 2014. Based on qa assessment, the product met specifications at the time of release. The root cause cannot be determined conclusively. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2015-06160 |
| MDR Report Key | 4796031 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-05-26 |
| Date of Report | 2015-09-01 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-05-26 |
| 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. EDDIE DARTON, MD, JD |
| Manufacturer Street | MAIL STOP AB2-6 MAIL STOP R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| 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 | 2015-05-26 |
| Model Number | NA |
| Catalog Number | 8065751755 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2015-05-26 |