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

Model Number 1MTEC30

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

The cartridge is not an implantable device.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was noticed that after following all the surgical steps for manipulation, (preparation) the exit's channel (cartridge tip) was damaged by excessive tightening in an unknown number of cartridges.The injectors were changed as well as the assistant (user), and after further attempts the results were the same.Therefore, the box of injectors was changed.With the new injectors everything was normal.No patient involvement/injury reported.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device evaluation: a total of 83 cartridges returned in their original package.All cartridges returned sealed and unused.Three units out of eighty three were opened and inspected.No product damaged was observed on cartridges.The reported complaint issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6423116
• MDR Text Key: 70519268
• Report Number: 2648035-2017-00538
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)191024(10)CB41214
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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: 10/24/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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