MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigation request for this production order (po) number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was initially reported that a z9002 14.5 diopter intraocular lens (iol) was explanted from the patient's eye as the physician believed that the lens was mislabeled with incorrect power.The patient measured +6 post-op.The 14.5 diopter lens was replaced another z9002 iol of a higher diopter (15.0).The patient was reported to be doing better.As a result of follow-up it was learned that the physician now believes that the implant was correctly labeled as the patient ended up a +6 again with the iol exchange of roughly the same power.Per the physician, the patient is getting another opinion.No further information was provided.
Additional Manufacturer Narrative
Pma #: p880081.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6692161
• Report Number: 2648035-2017-01216
• Device Sequence Number: 19078942
• Product Code: HQL
• UDI-Device Identifier: 05050474530584
• UDI-Public: (01)05050474530584(17)211115
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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: 11/15/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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