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

Model Number	Z9002
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, if explanted, give date: not applicable, as the intraocular lens was inserted and removed in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported intraocular lens (iol) was fully implanted in the patient¿s ocular sinister (left eye) and then removed because it wasn't seated in the capsule.No other lens was implanted and there was no patient injury.Through follow-up, additional information was received confirming no unplanned incision enlargement, no unplanned suture(s), and no unplanned vitrectomy.No additional information was provided.
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.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 08/18/2020.Section h-3 device returned to manufacturer: yes.Device evaluation: the z9002 lens was returned in its original package.Lens returned cut in two pieces.Loose fibers/particles were observed on lens pieces related the handling of the unit out of a sterile environment.Residues of lubricant material was also observed on lens pieces.Both haptics were observed damaged/distorted.The condition in which the sample returned is consistent with a lens that was implanted and removed.The complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 10423149
• Report Number: 2648035-2020-00625
• Device Sequence Number: 2942728
• Product Code: HQL
• UDI-Device Identifier: 05050474530492
• UDI-Public: (01)05050474530492(17)241108
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 10/25/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/16/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005