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

Model Number	AAB00
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date/explant date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the physician noted the capsule was loose during capsulotomy, but was able to complete the procedure.When the intraocular lens (iol) was injected into the patients left eye, the iol would not center and the zonules were severely disrupted.The iol was removed from the eye and an anterior chamber lens was implanted.Sutures were used and the patient was doing well.Additional information received reported that a vitrectomy was performed due to a capsular tear after the iol was implanted.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received.As a result, the following fields have been updated: device available for evaluation; returned to manufacturer on: 2/7/2020.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection was performed.Residues of viscoelastic were observed on the lens optic body and haptics.The lens was observed to be cut across the optic body, but it wasn't completely separated in two pieces, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further evaluation could be performed.The complaint issue could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.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(b)(4).

• 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: 9695936
• Report Number: 2648035-2020-00124
• Device Sequence Number: 11198174
• Product Code: HQL
• UDI-Device Identifier: 05050474548640
• UDI-Public: (01)05050474548640(17)231102
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 10/25/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/11/2020; 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: Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005