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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 Crack (1135); Inaccurate Delivery (2339); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2022
Event Type  malfunction  
Manufacturer Narrative
Weight and ethnicity: unknown; requested but not provided.If implanted, give date: not applicable, as the lens was not fully implanted.If explanted, give date: not applicable, as the lens was not fully implanted.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 have been made to obtain additional information regarding the event and to obtain suspect product for evaluation; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that the intraocular lens (iol) was partially inserted in the left eye and then removed due to the lens stuck in the cartridge and tip was cracked/deformed.The cartridge and lens made contact with the patient's eye.The lens is still in the cartridge but the cartridge split.No further information received.
 
Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 6, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received stuck inside of the cartridge tip with the plunger rod overriding the lens.The cartridge tip could be observed bulging around the lens.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.The lens was removed and, both haptics were detached.The lens could also observed to be torn and damaged.The complaint issue " dc-stuck in cartridge" and ¿dc-cartridge tip cracked/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.The complaint issue of ¿iol: dc-delivery issue¿ was not confirmed.The other observed issue of "dc-override" found during the product evaluation is related to the code of ¿iol: dc-delivery issue", however, it could not be confirmed to be related to a manufacturing or design issue.The remaining observed issues found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Corrected data: upon further review it was noted that "g4" field which should have been populated with "no" was inadvertently left blank on the initial mdr; therefore, the information has been corrected in this supplemental mdr report and the following fields have been updated accordingly: section g4: combination product: no.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 Key16275381
MDR Text Key308784908
Report Number3012236936-2023-00210
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474635944
UDI-Public(01)05050474635944(17)251010
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 02/26/2023
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 NumberDCB0000130
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 01/09/2023
Initial Date FDA Received01/31/2023
Supplement Dates Manufacturer Received02/14/2023
Supplement Dates FDA Received02/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2022
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 Age63 YR
Patient SexFemale
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