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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS

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AMO PUERTO RICO MFG. INC. TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number DIU300
Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Age or dob, weight, ethnicity: unknown, information not provided. Date of event: unknown, not provided, but the best estimate date is during 2021. If implanted, give date: not applicable, as there is no indication that the lens was implanted. If explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that two preloaded intraocular lenses (iols) were sterile compromised as the packaging was not fully intact. One of the lens package had a little hole by the knob and the other was completely ripped at the fold by the knob. The devices were not damaged. However, one box looked like it might have been damaged during shipping, but the serial number of the box could not be confirmed. There was no patient contact with the lenses. Through follow-up, it was clarified that the sterile pouch was damaged on both iols. The box was damaged on just one of the lens. No further information was available. This report captures one of the lens and a separate report is being submitted for the other lens.
 
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Brand NameTECNIS IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
AMO PUERTO RICO MFG. INC.
road 402 north, anasco ind. pk
anasco PR 00610
Manufacturer Contact
somyata nagpal
1700 e st andrew place
santa ana, CA 92705
7142478552
MDR Report Key12545007
MDR Text Key273787256
Report Number2020664-2021-07556
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474747609
UDI-Public(01)05050474747609(17)240718
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIU300
Device Catalogue NumberDIU300U140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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