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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dizziness (2194); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is (b)(6) 2019.(b)(6).(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that tecnis multifocal intraocular lens (model zlb00 +16.5 diopter) was explanted in secondary surgical procedure from patient¿s left eye because of patient experiencing dizziness due to mix match intraocular lens.A sensar monofocal intraocular lens (model ar40e +15.5 diopter) was used as the replacement.Later the sensar monofocal intraocular lens (model ar40e +15.5 diopter) was also explanted in secondary surgical procedure because of same reason, patient experiencing dizziness.A model zxr00 +16.5 diopter was used as the replacement lens for the patient.Patient's pre-op vision was 0.5.Post-op vision with the tecnis, zlb00 lens was 0.8.No further information provided.This report will capture information for second explant model (ar40e +15.5 diopter).A separate report is being sent for first explant model zlb00 +16.5 diopter).
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on 04/09/2019.Device evaluation: a small bottle was received.There was inside a cut lens.The lens was observed under microscope (10x) and the were marks on the optic zone.Due the condition of the lens received and since the complaint is related to a patient symptom, it could not be verified.A product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaint has been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: SENSAR
• 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: 8507511
• Report Number: 2648035-2019-00449
• Device Sequence Number: 19200329
• Product Code: HQL
• UDI-Device Identifier: 05050474502017
• UDI-Public: (01)05050474502017(17)230205
• Combination Product (Y/N): Y
• Initial Reporter Country: KR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 02/05/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/30/2019; 10/25/2020
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/28/2019; 11/12/2020
• 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
• Date Report Sent to FDA: 01/01/2005