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	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).Removed and replaced within initial procedure.If explanted; give date: n/a (not applicable).Removed and replaced within initial procedure.Attempts have been made to obtain additional information; however, to date a response has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the trailing haptic of a ar40m intraocular lens (iol) broke during insertion into the patient's operative eye.No surgical intervention required.No patient injury reported.No additional information was provided.
Additional Manufacturer Narrative
Additional information device available for evaluation: yes, returned to manufacturer on: 1/15/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site.Visual inspection using magnification was performed on the returned sample.Loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.Viscoelastic residue was observed on the lens.One of the haptic''s was observed distorted and detached.The detached haptic piece was not returned.No damaged was observed to the other haptic.The condition in which the returned lens was received is consistent with a lens that was handled and prepared for a surgical process.Based on the analysis of the return, there is no indication of product quality deficiency.The complaint issue reported was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no additional investigation requests have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue was 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 (b)(4) and capa-010215.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8251654
• Report Number: 2648035-2019-00076
• Device Sequence Number: 2190341
• Product Code: HQL
• UDI-Device Identifier: 05050474501829
• UDI-Public: (01)05050474501829(17)230905
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 09/05/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/22/2019; 10/25/2020
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 01/24/2019; 11/06/2020
• 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: EMERALD CARTRIDGE LOT CD00748; EMERALD CARTRIDGE LOT CD00748
• Date Report Sent to FDA: 01/01/2005