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

Model Number	AAB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
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)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of an aab00 21.0 diopter intraocular lens (iol) was noticed broken after implantation.Therefore, the lens was removed and replaced with an unknown model and diopter lens.There was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
Based on new investigation results, the following sections have been updated: device evaluation: the lens photo was provided and evaluated.It was observed cut in two pieces with one detached haptic.The reported issue was not verified; however, the detached haptic was observed.Due to the current condition of the lens, the cause of detached haptic could not be determined.Hence, a product quality deficiency was not determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: an aab00 lens box was received with an empty lens case, dfu (direction for use) and some identification labels.The lens was not received; therefore, the complaint could not be verified.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints have been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be 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 (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: 8210941
• Report Number: 2648035-2019-00003
• Device Sequence Number: 264889
• Product Code: HQL
• UDI-Device Identifier: 05050474548688
• UDI-Public: (01)05050474548688(17)211221
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial,Followup,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: 12/21/2021
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000210
• 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: 12/04/2018
• Supplement Date Received by Manufacturer: 01/22/2019; 02/26/2019; 10/25/2020
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/10/2019; 03/22/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005