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	Capsular Bag Tear (2639)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: unknown, not provided.Sex/gender: unknown, not provided.If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.(b)(6).Attempts have been made to obtain missing information; however, to date no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the implantation of the intraocular lens (model aab00 +19.5 diopter) breakage of the edge of the patient's anterior capsular bag was noticed.Reportedly, a 3-piece lens was implanted instead.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.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 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: 7948595
• Report Number: 3011852734-2018-00186
• Device Sequence Number: 857058
• Product Code: HQL
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)05050474548657(17)200824
• Combination Product (Y/N): Y
• 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): 11/03/2020
• 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: 08/24/2020
• 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: 09/10/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 10/25/2020
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 02/14/2019; 11/03/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005