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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

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AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS Back to Search Results
Model Number ZCU150
Device Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted, therefore not explanted.Section h3-81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported the zcu150 model intraocular lens (iol) was removed and replaced due to lens rotating and it became stuck in the cartridge.It was also indicated the iol was partially inserted however there was no medical or surgical intervention.The same procedure was completed using another zcu150 18.5 diopter iol.Patient status post-procedure was reported as patient has recovered.No further information is available.
 
Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 09-jun-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, scratches could be identified on the lens.No issues that could cause or contribute to the complaint issue could be identified.Complaint issue dc-delivery issue was not confirmed during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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Brand Name
TECNIS IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
AMO MANUFACTURING NETHERLANDS
van swietenlaan 5
groningen, groningen 9728 NX
NL  9728 NX
Manufacturer Contact
somyata nagpal
31 technology drive
irvine, CA 92618
7142478552
MDR Report Key16912988
MDR Text Key315032211
Report Number3012236936-2023-01209
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474657762
UDI-Public(01)05050474657762(17)241219
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/28/2023
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 NumberZCU150
Device Catalogue NumberZCU150U185
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/11/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2019
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
1MTEC30 CARTRIDGE LOT #: CM05497
Patient SexFemale
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