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U.S. Department of Health and Human Services

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

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AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS Back to Search Results
Model Number ZA9003
Device Problems Break (1069); Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2022
Event Type  malfunction  
Event Description
It was reported that an intraocular lens (iol) was partially inserted in patient's right eye, pinched trailing haptic.No report of other adverse events.No other information was provided.
 
Manufacturer Narrative
Age, weight, ethnicity: unknown/ not provided.Date of event: unknown, not provided.If implanted, give date: not applicable, as lens was not implanted if explanted, give date: not applicable, as lens was not implanted, hence not explanted.The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending 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.
 
Manufacturer Narrative
Additional information: follow-up information received that date of event was dec.5, 2022.Patient was fine post-op.Got a new iol without any difficulty.Field below updated: section b2: date of event: dec.5, 2022.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
Corrected data: in review, it was noted that the "g4" field which should have been populated with "no" was inadvertently left blank in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the field below has been updated accordingly: section g4: combination product: no.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: 1/20/2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: product evaluation was performed under magnification.The complaint lens presented with a chipped edge, haptic bent, and cosmetic issues from being crushed in the lens insert.The complaint issue dc-haptic damaged was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Dc-delivery issues and the other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 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 Key15973910
MDR Text Key308102564
Report Number3012236936-2022-03096
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474529021
UDI-Public(01)05050474529021(17)270925
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P990080
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,Followup,Followup
Report Date 02/09/2023
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 NumberZA9003
Device Catalogue NumberZA90030205
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 12/08/2022
Initial Date FDA Received12/13/2022
Supplement Dates Manufacturer Received12/15/2022
02/02/2023
02/09/2023
Supplement Dates FDA Received12/19/2022
02/08/2023
02/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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