MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MULTIFOCAL IOLS

Model Number	ZMA00
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt age/date of birth: unknown, not provided.Pt sex/gender: unknown, not provided.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after injection of an intraocular lens, model zma00, 15.0 diopter, surgeon was positioning the lens and the back haptic tore off during the manipulation.The lens was pulled out of the eye and a vitrectomy was conducted.It was noted that when the haptic tore off, it become completely detached from the optic.At that point a second intraocular lens, model zma00, 15.5 diopter was opened and during injection of this lens, the front haptic got stuck in the injector and folded on top of the optic and was kinked once the lens was pushed all the way out.This lens was then cut out of the eye and again a vitrectomy was conducted.A replacement lens (14.5 diopter) was then injected into the eye with no problem.There was no incision enlargement and no suture was required.This report is to capture the event of the first lens used, zma00 15.0 diopter.A separate mdr will be filed to capture the event related to the second lens used, zma00 15.5 diopter.
Additional Manufacturer Narrative
Device evaluation: the actual device was not returned to the manufacturer for evaluation only a package was returned.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6019623
• Report Number: 9614546-2016-00511
• Device Sequence Number: 902568
• Product Code: MFK
• UDI-Device Identifier: 05050474536708
• UDI-Public: (01)05050474536708(17)190623
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/23/2019
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC30, LOT NO. CB25067
• Outcome Attributed to Adverse Event: Required Intervention