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

Model Number	AAB00
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens remains implanted.If explanted, give date: not applicable, as the lens remains implanted.(b)(6).It was indicated that the device is not returning for evaluation as to date it remains implanted; 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 an aab00 19.5 diopter intraocular lens (iol) cracked upon insertion into the patient's operative eye.Reportedly, the lens remains implanted and the remnants of the cracked intraocular lens were removed during the irrigation/aspiration (i/a) procedure.No additional information was provided.
Additional Manufacturer Narrative
The initial mdr was submitted with an incorrect conclusion code.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, INC.; santa ana CA
• MDR Report Key: 8230655
• Report Number: 2648035-2019-00045
• Device Sequence Number: 16420670
• Product Code: HQL
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)05050474548657(17)220621
• Combination Product (Y/N): Y
• Initial Reporter Country: SG
• 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: 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: 06/21/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000195
• 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: 12/14/2018
• Supplement Date Received by Manufacturer: 03/01/2019; 10/25/2020
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 03/04/2019; 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