MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. DIOPTER J&J LENS 22.0; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  Injury  

Event Description

The loader made a loud noise and sprung rapidly through the bag behind the posterior chamber of the eye.Fda safety report id # (b)(4).

• Brand Name: DIOPTER J&J LENS 22.0
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 10837409
• MDR Text Key: 216415729
• Report Number: MW5097853
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: P980040/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention