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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.All pertinent information available to (b)(6) has been submitted.
Event or Problem Description
It was reported that the haptic was distorted.Patient contact was indicated.The customer then used the back-up lens.There was no report of incision enlargement, vitrectomy or sutures.It was stated that the patient is doing fine.No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation: yes, returned to manufacturer on 11/21/2018, device returned to manufacturer: yes.Device evaluation: sample was received and revealed that the lens was observed with viscoelastic residues and marks in the optic zone.One of haptic was observed positioned and bent, the other was observed distorted.Due the condition of the distorted haptic the condition could be caused by the handpiece pushrod.The complaint haptic damaged was verified in the return sample however it could be related to the handling process.No product quality deficiency was identified.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.A search in complaint history was performed which revealed that no similar complaint has been 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.No labeling changes are required.Conclusion: as a result of the investigation the complaint report was verified but could be related to the handling process.There is no indication of a product quality deficiency or product malfunction.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 (b)(4) and capa-010215.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8049540
• Report Number: 2648035-2018-01445
• Device Sequence Number: 13824091
• Product Code: HQL
• UDI-Device Identifier: 05050474501812
• UDI-Public: (01)05050474501812(17)230607
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 11/04/2020
• 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: 06/07/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 10/25/2020
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/08/2019; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT# CD09006; 1MTEC30 CARTRIDGE, LOT# CD09006
• Date Report Sent to FDA: 01/01/2005