MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-18 for INTREPID AUTOSERT IOL HANDPIECE 8065751755 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[31506237]
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
[31506238]
A customer reported that an intraocular lens (iol) handpiece injector cracked the iol cartridge during a cataract with iol procedure. The patient experienced an enlarged wound opening and wound leakage. Additional information has been requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
[35119164]
The company service representative examined the intraocular lens (iol) injector and found the tip was bent. The iol injector will be replaced. The iol injector was manufactured on june 2, 2014. Based on qa assessment, the product met specifications at the time of release. A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this product. A review of complaints for the last 24 months did not indicate any additional related reports for this iol injector serial number. A review of complaints for the last 24 months did not indicate any additional related reports for this system serial number. The reported event was replicated; however, what caused the plunger to bend upon contact with the cartridge remains inconclusive. Per the iol injector directions for use (dfu), during the pre-load function, the plunger should make initial contact with the cartridge at the ramp. Whether or not this was the issue the site experienced remains inconclusive. Another option of what caused the bend could be failure to follow the dfu on cartridge installation to the nosecone of the iol injector. The dfu is provided to the customer. The root cause of the reported event cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2015-09482 |
| MDR Report Key | 5233097 |
| Report Source | OTHER |
| Date Received | 2015-11-18 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2015-12-23 |
| Device Manufacturer Date | 2014-06-02 |
| Date Added to Maude | 2015-11-18 |
| 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 | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| 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 | 2015-11-18 |
| Model Number | NA |
| Catalog Number | 8065751755 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Other | 2015-11-18 |