MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Hole In Material (1293)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If implanted; give date: na (not applicable) the cartridge is not an implantable device.If explanted; give date: na (not applicable) the cartridge is not implanted, thus is not explanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the cartridge, a model 1mtec30, had a hole in it when it was removed from the sterile packaging.No further information was provided.

Manufacturer Narrative

Device available for evaluation - yes.Device received on 01/20/2016.The cartridge was returned to the manufacturer for evaluation.Visual inspection revealed small amount of viscoelastic solution and a hole was observed on the cartridge tube.There were no other defects or damage observed on the sample returned.The complaint for cartridge crack was confirmed.However, based on the condition of the sample returned, mishandling of the product could not be discarded.Manufacturing records review: a review of the manufacturing records for the cartridge was performed.During the manufacturing process, inspection of the neck, tube, and tip areas of the cartridge are inspected for cracks.No cracking or stress marks are allowed.The devices were manufactured within specifications.There were no associated deviation or non-conformity reports found in the manufacturing record review that were related to the reported complaint and/or similar issues.The units were released according to specification in compliance with the product intended use as required.A search revealed that this is the only investigation requested for this lot number that has been received at the time of this investigation.Labeling review: the directions for use, (dfu) instructions were reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the cartridge.As a result of the investigation there is no indication of a product quality deficiency and the reported complaint was verified, however a manufacturing related cause was not determined.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5358470
• MDR Text Key: 35615573
• Report Number: 2648035-2016-00046
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

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: 06/16/2016
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CA06521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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