MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INTREPID AUTOSERT IOL HANDPIECE; APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED

Catalog Number 8065751755

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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).

Manufacturer Narrative

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).

• Brand Name: INTREPID AUTOSERT IOL HANDPIECE
• Type of Device: APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: eddie darton, md, jd ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4796031
• MDR Text Key: 5819176
• Report Number: 2028159-2015-06160
• Device Sequence Number: 1
• Product Code: HQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention