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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 Problems Break (1069); Crack (1135); Mechanical Problem (1384); Failure to Advance (2524); Operating System Becomes Nonfunctional (2996)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2024
Event Type  malfunction  
Manufacturer Narrative
Section a2, a4, a5: unknown/asked but not provided.Section d6a: if implanted; give date: not applicable, as there was no patient involvement.Section d6b: if explanted; give date: not applicable, as there was no patient involvement.Section e1 telephone number: (b)(6).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 have been made to obtain missing information.However, the account did not provide the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that a preloaded monofocal intraocular lens (iol) injector failed and the lens was damaged.The surgeon stated it seemed the plunger went on top of the lens before going into the eye.The tip of the injector was split when the surgeon tried to fully expel the lens.Through follow up, it was learned that the nurse loaded the iol as standard and it didn¿t go into the eye.It was also reported there was a plunger rod issue and there was no patient contact.The issue was observed prior to insertion.The lens is not available.No other 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 Key18584949
MDR Text Key333825123
Report Number3012236936-2024-00182
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474731868
UDI-Public(01)05050474731868(17)260614
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDIB00
Device Catalogue NumberDIB00U0250
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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