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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: this event was initially included in vmsr filing 2648035-2021-00017.Due to the inclusion of other ancillary details that may appear as causes in the vmsr filing, this event is now being captured as an initial 30 day mdr.This report captures the event for serial number (b)(4).This is report number 11 out of 11 reports that are being submitted as initial individual mdrs.Additional information: date of birth or age at time of event: unknown/no information.Sex: unknown/no information.If implanted, give date: not applicable iol was not implanted.If explanted, give date: not applicable iol was not explanted.(b)(4).Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptic, which is consistent with a lens that was handled during insertion.Furthermore, a detached and a torn optic body were observed as well, which may have occurred during handling.Iol torn was confirmed, however per the initial report the complaint issue occurred during handling and therefore cannot be confirmed to be related to manufacturing.Device partially delivered and plunger rod issue could not be confirmed, because the lens was received outside/without the cartridge tip.No product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.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.
Event or Problem Description
Customer reported that upon inserting the intraocular lens (iol) into the patient¿s operative eye the lens tore, while using the plunger.There was patient contact with the product.Customer indicated that it could be a faulty plunger.The iol was taken out with no trouble, and a new lens was inserted.No further information was provided.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12170911
• Report Number: 2648035-2021-00067
• Device Sequence Number: 19215673
• Product Code: HQL
• UDI-Device Identifier: 05050474530683
• UDI-Public: (01)05050474530683(17)250225
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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
• Report Date (Section B): 07/14/2021

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: 02/25/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• 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: PLUNGER ROD, LOT UNKNOWN.