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

Model Number	AR40E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.The device has not been returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when inserting a model ar40e 3.5 diopter intraocular lens (iol) into the eye, the haptic broke off.There was patient contact; however, there was no patient injury.There was no incision enlargement, no serious patient injury, no suture(s), no vitrectomy, and the same model lens was used and successfully implanted.No additional information was provided.
Additional Manufacturer Narrative
Additional information device available for evaluation: yes, returned to manufacturer on: 01/09/2019.Device returned to manufacturer: yes.Device evaluation: returned lens was received in the original folding carton.The lens was cut and missing a portion including a haptic.Traces of viscoelastics are on the les surface indicating it was handled at the surgical stage.The haptic returned was found complete and attached to the portion of the optic zone.There is no damage on the haptic returned.The reported haptic detached could not be verified; the lens was incomplete and the lens was handled at the surgical stage.Therefore, a product quality deficiency could not be determined.The reported issue was not verified as incomplete lens was returned.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 additional investigations was 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.The reported issue was not confirmed.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 & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8207308
• Report Number: 2648035-2018-01691
• Device Sequence Number: 14113620
• Product Code: HQL
• UDI-Device Identifier: 05050474514072
• UDI-Public: (01)05050474514072(17)230815
• 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): 11/06/2020
• 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: 08/15/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 10/25/2020
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 01/21/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005