MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON DUET; OVDS

Model Number 10-2200-10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that endocoat had malfunctioned.The cannula was attached but the ophthalmic viscoelastic device (ovd) came out from the side during the procedure.The customer had the guard on, so there was no patient injury.The customer tried tightening the cannula, but the ovd still came out of the side; the cannula did not completely detach.The customer had to use a new product.

Manufacturer Narrative

Device available for evaluation ¿ yes, returned to manufacturer on 01/18/2017.Device returned to manufacturer ¿ yes.Device evaluation: the syringe unit was returned with the cannula guard attached, however the cannula was not returned to lifecore.Functional evaluation could not be completed because the cannula was not received.Evaluation of the returned syringe with a stock cannula could not replicate any attachment issues due to the luer lock connection.The cannula was able to fully engage with the luer lock.The cannula did not detach when force was applied to pull the cannula from the syringe.No root cause related to the manufacturing process could be identified based on the review of the batch record and receiving inspection reports.The investigation shows that the raw material syringes and cannulas used were found to be acceptable and that the final product lot meets the product specifications.Since the root cause is not likely to the manufacturing process, no actions recommended at this time.This record review determined components were as intended when evaluated by lifecore's routine receiving inspection.Lifecore will continue to monitor and trend complaints of this type.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: HEALON DUET
• Type of Device: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; rapsgatan; uppsala 75182 ; SE 75182
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6134087
• MDR Text Key: 61084528
• Report Number: 3004750704-2016-00031
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)180131(10)026100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/20/2018
• Device Model Number: 10-2200-10
• Device Catalogue Number: 10290080
• Device Lot Number: 026100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1