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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS EYHANCE IOL WITH DELIVERY SYSTEM; INTRAOCULAR LENS Back to Search Results
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.
 
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Brand Name
TECNIS EYHANCE IOL WITH DELIVERY SYSTEM
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
MDR Report Key16284091
MDR Text Key308783703
Report NumberMW5114636
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberDIB00 + 20.5D
Device Catalogue NumberDIB00U0205
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2023
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexFemale
Patient EthnicityHispanic
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