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

Model Number	AR40E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and 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 one of the haptics of lens model, ar40e monofocal iol (intraocular lens) had twisted during its deployment in the anterior chamber, which made the implantation impossible.It was removed and replaced with another lens, which lengthened the procedure.The incision had to be enlarged.Sutures and vitrectomy were performed.There were no patient injuries nor adverse effects with second lens.No additional information provided.
Additional Manufacturer Narrative
The intraocular lens (iol) was not returned for visual evaluation.Should the material be returned at a later stage, the investigation will be re-opened and a supplemental report filed.Additional information: manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional complaints for this order number have been received.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 (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: 8376145
• Report Number: 2648035-2019-00252
• Device Sequence Number: 2371064
• Product Code: HQL
• UDI-Device Identifier: 05050474501898
• UDI-Public: (01)05050474501898(17)230814
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 08/14/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00070
• 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: 02/04/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 10/25/2020
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 09/03/2019; 11/10/2020
• 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
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005