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

Model Number UNKNOWN

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Additional information: brand name: unknown, information not provided.Model: unknown, information not provided.Catalog #: enter unknown, information not provided.Expiration date: unknown, information not provided.Serial #: udi is unknown as the serial number is unknown.Implant date: unknown, information not provided.Explant date: not applicable as lens was not explanted.The device is not returning for evaluation as it is still implanted.There was no model or serial number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufactured date: unknown, information not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Received report of an intraocular lens (iol) that was repositioned.The suspect iol model and serial number were not provided.Several follow-ups were done to get additional information regarding the reported event and to get iol details such as the serial number.The customer was able to confirm that the iol was a j&j lens, and that it was repositioned.However no more information was 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 nr-0148919 and capa-010215.

• Brand Name: UNKNOWN
• 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: 10209650
• MDR Text Key: 196932324
• Report Number: 2648035-2020-00458
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• 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
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR