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

Model Number 1MTEC30

Device Problem Delivery System Failure (2905)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

All pertinent information available to abbott medical optics has been submitted.

Event Description

The customer indicated the cartridge was defective as the intraocular lens (iol) was stuck in the delivery device.The inserter plunger went out the back of the cartridge instead of pushing lens out the end.The lens was removed from the eye and replaced with the same model during the same procedure.There was no incision enlargement, no sutures, no patient injury.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device evaluation: evidence of viscoelastic ovd (ophthalmic viscosurgical device) residues was detected inside the cartridge tube, indicating the device was handled and prepared for surgical use.Visual inspection at 10x microscope magnification was performed.A cartridge crack was observed at the cartridge tube/tip that could be related to the hand piece pushrod.The lens was not in the cartridge.The reported device problem codes of iol partially delivered, override, stuck in cartridge, could not be verified; however, a cartridge crack was observed on the returned cartridge.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 adequately provide instructions and precautions along with warnings for the proper use and handling of the device.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: 6004636
• MDR Text Key: 56941142
• Report Number: 2648035-2016-01560
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)170112(10)CB22327
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

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: 01/12/2017
• 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: 09/13/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ZCB00 IOL, SERIAL NUMBER (B)(4).
• Patient Age: 78 YR