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); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
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 9 out of 11 reports that are being submitted as initial individual mdrs.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that one additional complaint was received for this production order that is not related to the codes in this investigation.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was partially inserted into the patient¿s eye and then removed and replaced with a backup lens during the initial procedure due to it being torn.The customer stated that the outcome did not interfere with the activities of the patient¿s daily life, and the patient has recovered.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: 12170795
• Report Number: 2648035-2021-00064
• Device Sequence Number: 19215672
• Product Code: HQL
• UDI-Device Identifier: 05050474530737
• UDI-Public: (01)05050474530737(17)240626
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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
• 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: 06/26/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200220
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 67 YR