MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that broken haptics and cracked intraocular lens (model za9003) were noticed when the lens was about to be removed from the package.No patient contact was reported.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/17/2018.Device returned to manufacturer? yes.Device evaluation: the lens was received a the manufacturing site and is missing a piece of the lens, and a haptic.The broken section of the lens was not returned.A large scratch across the optical body was observed.Two (2) small stains that appears to be ovd (ophthalmic viscosurgical device) and/or balanced salt solution were observed.The results found suggest handling of the product at the surgical site.The lens insert was evaluated and no damage was observed.Based on the visual evaluation, a product deficiency could not be determined.However, the reported issue for a broken haptic was verified.The cracked/torn lens was not verified; however, lens was scratched.Manufacturing record review: manufacturing record review was performed and revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no additional complaints have been received for this production order.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.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7637308
• Report Number: 2648035-2018-00906
• Device Sequence Number: 1424705
• Product Code: HQL
• UDI-Device Identifier: 05050474528895
• UDI-Public: (01)05050474528895(17)220912
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/12/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005