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

Model Number 1MTEC30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

This is not an implantable device.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that there was lint/viscous material introduced into the eye during insertion of the intraocular lens (iol) using the 1mtec30 cartridge.The lint/foreign material was aspirated out of the eye by using a cannula and was discarded.The iol remains implanted, and the patient appears to be doing well without any visual issues or injuries.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device evaluation: the product was not returned for evaluation as it was discarded.However, there was a customer video provided by the customer.The video was evaluated.During the lens implantation, it was observed that there was a foreign material on the lens.The foreign material was removed from the lens.Based on the evidence observed and since the cartridge and / or the substance are not available for a thorough evaluation, it is not possible to confirm if the condition reported (viscous material) was related to in-line manufacturing practices/process or a result of the lens being handled by the surgery site.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: 7061955
• MDR Text Key: 93229505
• Report Number: 2648035-2017-02175
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180823(10)CC10474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/23/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC10474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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