MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS EYHANCE IOL WITH DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number DIB00 + 20.5D

Device Problems Contamination (1120); Packaging Problem (3007)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 01/23/2023

Event Type  Injury  

Event Description

When the intraocular lens was inserted into the eye, md noticed white debris (packing material) after unfolding lens.Debris irrigated out.Debris seen as black specs in the eye.

• Brand Name: TECNIS EYHANCE IOL WITH DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 16284091
• MDR Text Key: 308783703
• Report Number: MW5114636
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DIB00 + 20.5D
• Device Catalogue Number: DIB00U0205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic