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	Visual Disturbances (2140); Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.If explanted, give date: not applicable as the lens remains implanted.Device evaluation: the device was not returned to the manufacturer for evaluation.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 that no other complaint was received from this production order.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 the manufacturer has been submitted.
Event or Problem Description
It was reported that a patient had cataracts done last (b)(6).The patient's right eye is stellar, however the left eye has a ghost reflections and an image of a fly wing in lower lights off headlights and led lights.The irregularities disappears if the patient looks up.The patient and her physician are discussing the possibility of a flawed or wrong iol in that left eye.Patient stated that she has great vision with the right eye, but this left eye is quite bothersome.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the intraocular lens was explanted on (b)(6) 2017.A pars plana vitrectomy was performed.The lens ar40e +14.00 diopter was implanted as a replacement.The patient was seen by the surgeon on (b)(6) 2017 and her vision was reported as good.The explanted lens was discarded.The following fields were updated: outcomes attributed to adverse event: updated from other to required intervention.If explanted, give date: (b)(6) 2017.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6559925
• Report Number: 2648035-2017-00850
• Device Sequence Number: 16167530
• Product Code: HQL
• UDI-Device Identifier: 05050474531581
• UDI-Public: (01)05050474531581(17)200719
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 07/19/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 04/09/2018
• 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; Required Intervention