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

Model Number AAB00

Device Problems Dent in Material (2526); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown, not provided.If implanted; give date: unknown/not provided.If explanted; give date: n/a (not applicable).To date, the lens remains implanted.(b)(6).Device evaluation: product testing could not be performed since the product was not returned for evaluation as it remains implanted.The customer's reported complaint could not be verified.Manufacturing records evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this production order number have been received.The directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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.

Event Description

It was reported that the sensar lens model, aab00 monofocal iol (intraocular lens) was very cold during implantation as it unfolded little slower than usual.In addition to the outer rim of the lens (the non-optic part), lens reportedly seemed to be dented or scratched after implantation.There was no significant delay during the procedure nor visual issues for the patient.As a result of the good outcome, the lens remains implanted.No additional information provided.

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
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8360779
• MDR Text Key: 136844462
• Report Number: 2648035-2019-00222
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474548718
• UDI-Public: (01)05050474548718(17)220817
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1