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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The lens was removed in the initial procedure.If explanted; give date: n/a (not applicable).The lens was removed in the initial procedure.(b)(4).Device evaluation: the product was not returned to the manufacturing site; therefore, the complaint issue reported was not 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 could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported after an implantation of a monfocal sensar intraocular lens (iol) model aab00, the physician observed the patient¿s posterior capsule was not able to support the implant.Therefore, a removal and replacement of the iol was performed.There was an incision enlargement to remove the iol and a suture was placed to close the wound.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 12/31/2018.Device returned to manufacturer? yes.Device evaluation: the returned sample was received loose inside its original box along with its daisy wheel and inserts.The product was visually inspected with the unaided eye showing the lens was cut in half most probably to aid in explant.No obvious defects were observed with the haptics.Due to the condition of the return, no further analysis is possible.The complaint issue reported was not 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 nr-0148919 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: 8225874
• Report Number: 3011852734-2019-00009
• Device Sequence Number: 16650965
• Product Code: HQL
• UDI-Device Identifier: 05050474548633
• UDI-Public: (01)05050474548633(17)220725
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 10/25/2020
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/22/2019; 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
• Date Report Sent to FDA: 01/01/2005