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	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that the incision had to be enlarged on the left eye (os) of a male patient in order to remove the implanted intraocular lens (iol), model za9003 within the same surgical procedure.It was reported that the posterior capsule bag tore; however, it was confirmed that the capsule tear was due to patient anatomy issue and it was not related to the lens or any of the amo products.The doctor claimed that there was no capsular support hence, he had to do incision enlargement to remove the lens and vitrectomy was also performed.It was indicated that there was no replacement lens used and that the patient went home aphakic.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 4/22/2017.Device returned to manufacturer? yes.Device evaluation: the lens was returned to the manufacturer for evaluation.The received lens was observed with viscoelastic residues and with some scratches in the optic zone.The haptics were observed bent.This condition of the lens is typical of a lens that has been removed.There was no complaint against the lens and the reported complaint could not be verified since this is a patient condition issue and as the customer stated the capsule tear was due to patient anatomy (no capsular support hence).Manufacturing record review: a manufacturing record review was performed and no non-conformance reports associated with this production order were found.The device was manufactured according to specification.The complaint history search revealed that no other complaint have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6491429
• Report Number: 2648035-2017-00676
• Device Sequence Number: 1268376
• Product Code: HQL
• UDI-Device Identifier: 05050474529090
• UDI-Public: (01)05050474529090(17)210225
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 02/25/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC30 CARTRIDGE, LOT #CB35535
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR