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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a za9003 24.5 diopter intraocular lens (iol) was removed from eye due to an increase in ocular pressure.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported that the insertion date (date of event) was (b)(6) 2017.Also, there was an incision enlargement performed and no replacement lens was used.The doctor's name was dr.(b)(6).The patient left in good condition and aphakic.No additional information was provided.As a result of the additional information received and receipt of the complaint product the following fields have been updated accordingly: device available for evaluation?: yes, returned to manufacturer on 08/14/2017.Device returned to manufacturer?: yes.(b)(6).The report of an explant in the initial mdr no longer applies as this has been determined to be an insertion and removal.The date provided in explanted date ((b)(6) 2017) has been corrected to not applicable, as this lens was inserted and removed.Additionally implanted date: if implanted, give date was provided as unknown/not provided, however this field has not been updated to not applicable as the lens was not implanted but inserted and removed.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed viscoelastic residues were observed on the lens optic, but no lens damages were observed.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6769876
• Report Number: 2648035-2017-01441
• Device Sequence Number: 16528837
• Product Code: HQL
• UDI-Device Identifier: 05050474529106
• UDI-Public: (01)05050474529106(17)220515
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: 05/15/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/06/2017
• Supplement Report FDA Received Date: 09/06/2017
• 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