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

Model Number	AR40M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex/ gender: unknown/ not provided.If implanted, give date: not applicable, as lens was removed/ replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/ replaced during the same procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) while being inserted into the eye had a loading issue.The reporter was not sure if there¿s a handling/ use error, but an incision enlargement was required.It was learned that the patient was supposed to receive a model ar40m iol, but as this suspect iol had loading error, instead of leaving the patient aphakic, the customer put in the smallest diopter lens that they had in stock, which was the zcb00 5.0d.There was no harm to the patient.They patient was actually very happy with the outcome.No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on 7/7/2020.Device evaluation: the lens was observed cut in two pieces with one of the haptics detached and missing.Customer states that lens had loading error.Product quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that one other complaint has been received for this production order number.Investigation was reviewed and is related to this complaint dc-loading issues.Investigation is in process and is from the same customer as this one and same cause (user error).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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10243262
• Report Number: 2648035-2020-00483
• Device Sequence Number: 573394
• Product Code: HQL
• UDI-Device Identifier: 05050474514218
• UDI-Public: (01)05050474514218(17)250207
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 02/07/2025
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/09/2020; 10/25/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/05/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC30 LOT # CE02964; EMERALDC30 LOT # CE02964
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005