MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. PRECISION LENS 10L; INTRAOCULAR LENS

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 08/12/2020

Event Type  Injury  

Event Description

Lens broke in eye.Haptic was broken when the lens was deployed into the eye.Fda safety report id# (b)(4).

• Brand Name: PRECISION LENS 10L
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 10425123
• MDR Text Key: 203654601
• Report Number: MW5096120
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2020

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: 10/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention