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 Code	No Code Available (3191)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a za9003 24.5 diopter intraocular lens (iol) would not sit properly in the capsular bag during implantation.The lens was removed and the patient was sent home aphakic as the patient's anatomy could not handle the replacement lens.Sutures were required.The patient came back for a secondary procedure and had a sulcus iol implanted.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 12/1/2017.Device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.Visual inspection at 10x microscope magnification revealed that lens returned was cut in three pieces.Loose fibers/particles were observed on lens pieces related the handling of the unit out of a sterile environment.Residue of lubricant material and material which looked like body fluids were also observed on lens pieces.Both haptics were observed damaged/distorted.The complaint issue reported could not be verified.Manufacturing record review: manufacturing records were reviewed.The units were manufactured and released according specification.A search complaints revealed no additional investigation requests 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 product.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 92705
• MDR Report Key: 6989349
• Report Number: 2648035-2017-01990
• Device Sequence Number: 118244
• Product Code: HQL
• UDI-Device Identifier: 05050474529106
• UDI-Public: (01)05050474529106(17)181009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 10/09/2018
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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: Required Intervention