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

Model Number	Z9002
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when opening z9002 18.0 diopter intraocular lens (iol) the lens haptic was stuck in plastic turn and broke off.Through follow up, customer account provided additional information confirming there was no patient contact.The procedure was completed successfully using backup lens with same model and diopter size without any complications.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 01/16/2019.Device returned to manufacturer: yes.Device evaluation: product returned was received in its original packaging.According to the visual inspection, loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.Residues of viscoelastic material was observed on lens.One part of the lens edge was observed bend.One of the haptic was observed detached.The detached haptic piece was not returned.No damaged was observed to the other haptic.The reported issue was verified.Based on the analysis of returned product there is no indication of product quality deficiency.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no additional investigations was received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was confirmed.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 nr-0148919 and capa-010215.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8198388
• Report Number: 2648035-2018-01660
• Device Sequence Number: 13492422
• Product Code: HQL
• UDI-Device Identifier: 05050474530652
• UDI-Public: (01)05050474530652(17)220501
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 05/01/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 10/25/2020
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/21/2019; 11/06/2020
• 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