MAUDE Adverse Event Report: JOHNOSN & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE ASPHERIC ACRYLIC; INTRAOCULAR LENS

Catalog Number PCB0000195

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  Injury  

Event Description

Part of the lens inserter broke off into the eye of the patient when the lens was deployed; almost pulling the lens implant back out as the inserter was removed.The piece was retrieved without damage to the implant.Fda safety report id# (b)(4).

• Brand Name: TECNIS 1-PIECE ASPHERIC ACRYLIC
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNOSN & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 10521204
• MDR Text Key: 206817172
• Report Number: MW5096557
• Device Sequence Number: 1
• Product Code: HQL
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• 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