MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication at the time of this report that the lens has been explanted.(b)(4).Unexpected postop refraction.Complaint device was not returned for evaluation.The reported issue could not be confirmed.The manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The units were released according to specification.The manufacturing results for lens diopter was 16.9, and was found within specifications.A review of the complaints related to the production order was performed and the results revealed no other complaints for this order number.A historical complaint data review was performed and results did not identify any product deficiency.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after implantation of a zcb00 intraocular lens (iol), a patient experienced a problem seeing both distance and reading with a lot of fuzziness.Reportedly, patient has seen many different surgeons and optometrist and they have given her contacts lenses and glasses.Patient had yag in (b)(6) 2016, and patient can drive though most of the letters are still fuzzy and she needs glasses when using the computer.Reportedly, patient did not have any serious medical condition.Patient plans to see another doctor for her visual concerns.No further information was provided.This report represents the lens implanted in patient's left eye.A separate report is being filed for the lens implanted in patient's right eye.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5912771
• Report Number: 2648035-2016-01352
• Device Sequence Number: 635925
• Product Code: HQL
• UDI-Device Identifier: 05050474531659
• UDI-Public: (01)05050474531659(17)190619
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/29/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 06/19/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2016
• Initial Report FDA Received Date: 08/29/2016
• 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: Other