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

Model Number UNKNOWN

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a healon endocoat vial did not have any labeling on the syringe.The package was opened, however the endocoat was not used.There was no patient contact or consequence.

Manufacturer Narrative

Additional information was received clarifying the endocoat came from the duet packaging and the healon was labeled.Furthermore, customer could not provide the lot number for the duet.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device evaluation: the syringe was not returned to the manufacturing site for investigation.A photograph of the reported syringe was provided to the manufacturing site for investigation.Evaluation of the product photograph confirms the complaint report.Visual inspection shows the syringe does not contain a syringe label.There is no visible label residue on the barrel of the syringe suggesting there was never a label applied to the syringe.Retain sample evaluation: visual evaluation of the product archive samples for other lots was performed.Review confirms that all 90 retain samples contained the required syringe label.Additional product archive inspection was performed for lots manufactured in 2015 and 2016.Review confirms that all 90 retain samples for each of the lots contained the required syringe label.Root cause was identified as an inadequate procedure as it does not provide specific instruction on handling the label priming operation.A secondary root cause related to the potential for a label to adhere to the equipment (label applicator) was also identified.A review of the manufacturing records for the syringe were not possible as the lot number was not provided.As a result of the investigation, a product deficiency was identified.All pertinent information available to abbott medical optics 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 751 8 2; SE 751 82
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6176014
• MDR Text Key: 62447810
• Report Number: 3004750704-2016-00034
• Device Sequence Number: 1
• Product Code: LZP
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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