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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported via returned product receipt that the haptic of a model za9003 intraocular lens (iol) was bent.Patient involvement and outcome were not provided.No additional information provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on: 07/17/2018.Device evaluation: the device was received at the manufacturing site for investigation.Visual inspection at microscope magnification was performed and lubricant material residues were observed on the lens surface.Slightly distortion/bent was observed on one of the haptic, the other haptic was detached and it was not returned.The reported issue was verified.However, the conditions in which the sample was returned indicates that it was handled and prepared for surgical process.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.Historical data analysis: the search in complaint history revealed no additional complaint was 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 product.Conclusion: as a result of the investigation, 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: 7563645
• Report Number: 2648035-2018-00818
• Device Sequence Number: 178187
• Product Code: HQL
• UDI-Device Identifier: 05050474529144
• UDI-Public: (01)05050474529144(17)200112
• Combination Product (Y/N): Y
• 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): 08/24/2018
• 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: 12/01/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030265
• 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: 05/03/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 06/02/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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