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

Model Number	AR40E
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Improper or Incorrect Procedure or Method (2017); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had handling problem,unfolding issue and was improperly loaded.There was contact with the patient¿s right eye.The lens was removal and replacement.There was no incision enlargement or vitrectomy performed.However, a suture was placed as a result of a leak of the wound at the end of the surgery, therefore a suture on the wound in temporal (2.2).The replacement lens was the same model but a half diopter higher.The patient was doing good when discharged.No further information provided.
Additional Manufacturer Narrative
Device evaluation: as the product does not return for the evaluation, the complaint cannot be confirmed and either a product deficiency can be confirmed.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.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: 9422098
• Report Number: 2648035-2019-01293
• Device Sequence Number: 11302327
• Product Code: HQL
• UDI-Device Identifier: 05050474501867
• UDI-Public: (01)05050474501867(17)200623
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 06/23/2020
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 10/25/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/31/2019; 11/05/2020
• 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: 59 YR
• Date Report Sent to FDA: 01/01/2005