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

Model Number 1MTEC30

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

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

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device evaluation: the cartridge was not returned to the manufacturer; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing record review and related documents revealed the cartridge was manufactured and released according to specification.Labeling review: the directions for use (dfu) for the cartridge was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the cartridges.As a result of the investigation there is no indication of a product quality deficiency and the reported complaint could not be verified.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that there was some resistance with the cartridge when injecting the intraocular lens (iol).Follow up information revealed that the lens was implanted and was scratched.The cartridge was discarded.No further information was provided.Two cartridges were reported therefore two mdrs will be filed.This is 1 of 2.

• 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: 5685625
• MDR Text Key: 46110825
• Report Number: 2648035-2016-00817
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/12/2017
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CB22328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• 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