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

Model Number	ZMA00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted as it was not centering properly and was likely due to a crimped or damaged haptic.Another lens, same model was implanted and the patient was reported doing well.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up it was learned that the lens was explanted from a female patient's left eye.A vitrectomy and 7mm clear corneal tunnel, 10.0 nylon bow tie suture were required.Additionally, the following information was provided.Age/date of birth: (b)(6)0 gender/sex: female.Date of event: (b)(6) 2016.If implanted, give date: (b)(6) 2016.If explanted, give date: (b)(6) 2016.(b)(4).Device available for evaluation ¿ yes, returned to manufacturer on 12/7/2016.Device returned to manufacturer ¿ yes (device evaluation anticipated, but not yet begun).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the explanted intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection of the returned lens sample shows the product is damaged.Non production related scratches are present on the anterior side of the lens.These scratches are most likely related to handling and or the lens explant procedure.No anomalies were found on the haptics.The customer's reported complaint could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The product was manufactured according to specification.A search of complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.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: 6084438
• Report Number: 9614546-2016-00574
• Device Sequence Number: 757351
• Product Code: MFK
• UDI-Device Identifier: 05050474536807
• UDI-Public: (01)05050474536807(17)200121
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/21/2020
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 12/08/2016; 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention