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

Model Number	AR40M
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: not applicable; lens removed/replaced within the initial procedure.If explanted, give date: not applicable; lens removed/replaced within the initial 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) was damaged during folding with partial insertion into the eye.There was no vitrectomy or incision enlargement performed.Sutures were done as a result of the damaged haptic.Patient is doing good post-op.Lens was replaced with a non j&j lens.No other information provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on 08/12/2019.Device evaluation: the returned sample was received with original packaging (folding carton), lens case.A visual inspection was performed, the following were the observations: particles/fibers were in lens surface(body) also, the lens was cut in the two pieces.The two haptics(loops) were inserted in the lens body.One of the haptic (loop) was distorted, the other haptic(loop) was in good conditions.The complaint issue haptic damaged was verified.Based on the visual evaluation of the returned unit, it could not be determine that the cause of the issue reported is related to the manufacturing process since there are indications the unit was handled and explanted.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaint has been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8880327
• Report Number: 2648035-2019-00866
• Device Sequence Number: 290463
• Product Code: HQL
• UDI-Device Identifier: 05050474501836
• UDI-Public: (01)05050474501836(17)230420
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 10/25/2020
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/14/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005