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

Model Number	ZA9003
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Corneal Edema (1791); Vitrectomy (2643); No Code Available (3191)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that lens was inserted and removed in same surgical procedure because the surgeon could not center the lens.Reportedly vitrectomy and sutures were required during this procedure.No lens was implanted.Additional information was received, and it was learnt that patient was left aphakic and plans are to refer the patient out.No other issues with lens.The procedure lasted for one hour and nine minutes and a maluygin ring was used.Patient is doing better, and patient¿s clouding is improving.No further information provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 7/14/2020.Device evaluation: the product was returned.Visual inspection performed under microscope.Lubricating material residues and loose particles can be observed on the lens surface.Both haptics looks slightly distorted.With the information provided and the condition of the product returned the reported issues could not be verified.Based in the analysis the product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the device were reviewed.The search revealed no additional complaint was received from 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.
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
• 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: 10242205
• Report Number: 2648035-2020-00473
• Device Sequence Number: 2679453
• Product Code: HQL
• UDI-Device Identifier: 05050474528987
• UDI-Public: (01)05050474528987(17)241031
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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: 10/31/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 10/25/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/05/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005