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

Model Number	AR40E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
When inserting the ar40e 5.5 diopter intraocular lens (iol) into the patient's operative eye, it was reported that the haptic was bent and would not unbend in the eye.Reportedly, the lens had to be cut out of the eye.An incision enlargement was required and sutures were used.The procedure was completed successfully using a back-up lens with the same model and diopter size.The patient outcome was reported as fine.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 01/22/2019.Device evaluation: the lens returned in its original box and case.The lens was observed cut.Visual inspection using microscope magnification was performed.Only two pieces of lens was returned.Haptic damaged was observed in one the lens pieces, confirming the reported issue.Based on the evidence observed, there is no indication that the complaint sample has been affected by the manufacturing process.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no other 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.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.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(b)(4).

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8251980
• Report Number: 2648035-2019-00079
• Device Sequence Number: 1582659
• Product Code: HQL
• UDI-Device Identifier: 05050474514096
• UDI-Public: (01)05050474514096(17)230126
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 11/06/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/20/2019; 10/25/2020
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/19/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005