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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 during cataract surgery a piece of plastic was observed in the eye anterior chamber and it was removed by the surgeon.Both the intraocular lens (iol) and the cartridge were reported as being suspect sources of the plastic particle.No further information was provided.Two mdr will be filed.This report is to record the cartridge.

Manufacturer Narrative

Additional information was received and it was learnt that the intraocular lens (iol) was fully implanted when the piece of plastic was noticed in the patient's eye.There was no incision enlargement, no vitrectomy was performed and no patient injury was reported.The patient outcome was reported as normal.(b)(4).Device evaluation: neither the cartridge or the piece of plastic were returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 6408574
• MDR Text Key: 70065845
• Report Number: 2648035-2017-00501
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)171227(10)CB43262
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/27/2017
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CB43262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• 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
• Treatment: ZCB00 LENS, SERIAL NUMBER (B)(4)