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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

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AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS Back to Search Results
Model Number DCB00
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2023
Event Type  malfunction  
Manufacturer Narrative
Section a2, a4, and a5: not applicable, as there was no patient contact.Section d6a: if implanted, give date: not applicable, as there was no patient contact.Section d6b: if explanted, give date: not applicable, as there was no patient contact.Section h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain additional information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that the preloaded intraocular lens (iol) "would not load properly" in the cartridge, "stayed folded", and was "twisted in the cartridge", which was visible and not able to be used for the patient.The lens was completely folded over and stuck together in the cartridge; "it was folded before being pushed into tip".It was also noted that the haptic was damaged.The issue was noticed while loading, prior to insertion.There was no patient contact.The issue was not due to use error.The procedure was completed successfully using a back-up lens (same model and diopter).Balanced salt solution (bss) with no additives was used at room temperature as a cartridge lubricant.No further information was provided.
 
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Brand Name
TECNIS SIMPLICITY
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
AMO PUERTO RICO MFG. INC.
road 402 north, anasco ind. pk
anasco PR 00610
Manufacturer Contact
somyata nagpal
31 technology drive
irvine, CA 92618
7142478552
MDR Report Key17136553
MDR Text Key317780656
Report Number3012236936-2023-01507
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474636002
UDI-Public(01)05050474636002(17)251212
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
Reporter Occupation Physician
Type of Report Initial
Report Date 06/15/2023
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 Operator Health Professional
Device Model NumberDCB00
Device Catalogue NumberDCB0000160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/23/2023
Initial Date FDA Received06/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALANCED SALT SOLUTION (BSS)
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