MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION 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	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Attempts had been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that the intraocular lens, with patient contact, tore while inserting the lens into the eye.There was no patient injury reported and no incision enlargement required.Patient has recovered.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 10/8/2018.Device returned to manufacturer? yes.Device evaluation: the device was received in the original package (folding carton), in the lens case at the manufacturing site for investigation.Visual inspection using magnification was performed and the lens was observed cut in two pieces.The haptic were observed inserted in the lens, also no cosmetic defect was observed to the loops.The lens was observed under microscope and viscoelastic residues were observed in the optic zone and haptics.The reported issue as improperly loaded, iol torn could not be verified.There is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Manufacturing record review: the manufacturing records for the device were reviewed.The review identified no deviation or non-conformity report related to this production order.The product was manufactured and released according to specification.A review of the complaint history revealed that no additional complaint has 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 product.Conclusion: 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 johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7931551
• Report Number: 2648035-2018-01292
• Device Sequence Number: 1859289
• Product Code: HQL
• UDI-Device Identifier: 05050474529113
• UDI-Public: (01)05050474529113(17)230122
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/20/2018; 10/25/2020
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/26/2018; 11/03/2020
• 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: EMERALD CARTRIDGE, LOT UNKNOWN
• Date Report Sent to FDA: 01/01/2005