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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 DIB00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Eye Injury (1845)
Event Date 03/26/2024
Event Type  Injury  
Event Description
It was reported that the preloaded intraocular lens (iol) was implanted in the patient's left eye and vitrectomy occurred.The lens was cut out in the same procedure and vitrectomy was performed and three piece new non jnj iol was inserted.From additional information it was learnt that the lens was removed in order to perform vitrectomy safely.There was issue with duovisc (viscoelastic).The patient was discharged in a stable condition.There was no medical/surgical intervention required.There was no use error.No other information is available.
 
Manufacturer Narrative
Unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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.
 
Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 04/22/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the suspect product revealed there was damage present on the plunger rod tip that could be attributed to damage that occurred during shipping.The cartridge was presented with viscoelastic residue dispersed through the length of the cartridge.The lens module was inspected and no damaged or viscoelastic residue was present.The lens present cosmetic damaged to the optic body and haptics.No further evaluation was performed.The complaint issue "hm-unspecified injury", "pt-unplanned vitrectomy", and "pt-removal and replacement " were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there was no product deficiency or product malfunction that could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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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 Key19127232
MDR Text Key340408644
Report Number3012236936-2024-01122
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474731769
UDI-Public(01)05050474731769(17)260503
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 Physician
Type of Report Initial,Followup
Report Date 05/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDIB00
Device Catalogue NumberDIB00U0205
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 03/27/2024
Initial Date FDA Received04/17/2024
Supplement Dates Manufacturer Received05/13/2024
Supplement Dates FDA Received05/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2023
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 Outcome(s) Required Intervention;
Patient Age79 YR
Patient SexFemale
Patient Weight55 KG
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