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

Model Number 1MTEC30

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2017

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 during handling but prior to insertion of an intraocular lens into the patient's eye, a hole was observed on the cartridge, on the side down by the tip.There was no patient contact.Reportedly, the lens was in the cartridge and the procedure was completed using a backup lens with the same model and diopter size.No further information was provided.

Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on 10/06/2017.Device returned to manufacturer?: yes.The product was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residue of lubricant material on the cartridge.It was also slightly distorted and a crack was observed at the cartridge tip.The lens was also observed stuck at the tube area.The condition of the returned product is consistent with a unit that has been previously handled and prepared for the surgical process.The complaint issue reported was verified.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed no additional investigations request for this production order number.The directions for use (dfu) was reviewed.The 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 was 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: 6914601
• MDR Text Key: 88232931
• Report Number: 2648035-2017-01793
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180601(10)CC06685
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC06685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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
• Treatment: ZCB00 LENS, SERIAL NUMBER (B)(4)