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

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2020

Event Type  No Answer Provided  

Event Description

Lens did not deploy; stuck in delivery device.Fda safety report id# (b)(4).

• Brand Name: PRECISION LENS 10L
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 10425108
• MDR Text Key: 203659677
• Report Number: MW5096119
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• 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