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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that lens was explanted from patient¿s operative eye in secondary surgical procedure because of patient experiencing astigmatism.Reportedly the patient had 0.25 diopter of astigmatism prior to cataract surgery but had 2.25 diopter after the cataract surgery.Hence a toric lens was implanted as replacement lens to counteract the astigmatism.No further information provided.
Additional Manufacturer Narrative
Correction: date of event: additional information was received and it was learnt that the correct date of event when the patient saw first symptom was (b)(6) 2020.Initially it was inadvertently populated as (b)(6) 2020.Additional information: additional information was received and it was learnt that patient is doing well.Age/date of birth: (b)(6).Device available for evaluation; returned to manufacturer on: 7/9/2020.Device evaluation: the product was returned.Visual inspection performed under microscope.Lubricant material residues and loose particles can be observed on the lens surface.The lens was cut into pieces and both haptics looks slightly distorted which could be related to removal process.Based on the reported issue there is no product quality deficiency.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: 10247565
• Report Number: 2648035-2020-00485
• Device Sequence Number: 16287040
• Product Code: HQL
• UDI-Device Identifier: 05050474528888
• UDI-Public: (01)05050474528888(17)241114
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• 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: 11/14/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 10/25/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/07/2020; 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: 66 YR
• Date Report Sent to FDA: 01/01/2005