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

Model Number	AAB00
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during a site visit a sales representative identified a spelling / typing error on the lens label.The device was identified as an aspheric posterior chamber biconvex intraocular lens; however, it should read as spheric instead of aspheric.There is no patient involvement.No further information provided.
Additional Manufacturer Narrative
In review, it was noted that that an emdr should not have been reported for this device as the event did not meet the criteria for a reportable malfunction event.Therefore, no further information will be provided under this medwatch #2648035-2019-00557.Device evaluation: the product was not returned; however, a photo was provided.The photo was evaluated and due to the photo provided, it is possible to confirm the complaint reported.Although there was a misprint, the label discrepancy is unlikely to impact the customer.Manufacturing records review: the manufacturing records for the product was reviewed.No non-conformance reports (nc) were found associated to this production order.The product was manufactured and released according to specification.A search on complaints revealed that no other complaint has been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation there is no impact to patient harm.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8598081
• Report Number: 2648035-2019-00557
• Device Sequence Number: 2293805
• Product Code: HQL
• UDI-Device Identifier: 05050474548749
• UDI-Public: (01)05050474548749(17)220816
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 11/11/2020
• 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: 08/16/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000240
• 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: 04/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 10/25/2020
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 06/06/2019; 11/12/2020
• 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