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 Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a small piece of plastic was found in the patient's eye and was removed.The customer suspects the particle came from the cartridge.It was reported that the patient appears to see very well.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on 4/22/2017.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned in a cartridge tray.The lens was observed stuck inside the cartridge at the tube zone.An insufficient amount of viscoelastic was observed inside the cartridge.The cartridge tip was observed broken.Visual inspection at 10x microscope magnification was performed.It could not be ruled out that the damage on the tip is associated to the handpiece plunger.There was no particle observed in the returned tray.The reported issue was not verified.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) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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: 6515059
• MDR Text Key: 73452273
• Report Number: 2648035-2017-00725
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)171205(10)CB42579
• 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,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/05/2017
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CB42579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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