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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 Crack (1135); Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2023
Event Type  malfunction  
Event Description
It was reported that a partially inserted intraocular lens (iol) was removed from a patient¿s right eye as the cartridge broke/cracked, cartridge tip cracked/deformed.It was indicated that there was patient contact and the issue was noted while inserting the lens into the eye.The procedure completed successfully using a replacement lens of the same model and diopter.The outcome did not significantly interfere with patient's activities of daily life and the patient has recovered.No further information was provided.
 
Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.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.Section h6: medical device problem code: 1135 - crack (cartridge tip cracked/damaged & cartridge crack).An attempt was made to obtain the missing information; however, the information was not available.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: may 2, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: handpiece was received in the handpiece tray in the original folding carton.Visual inspection under magnification revealed that the complaint handpiece was received in the handpiece tray suggesting that the plunger rod was fully retracted.The lens was found stuck in the tip of the cartridge.The cartridge and cartridge tip were deformed around the lens, no crack was identified.Trace amounts of viscoelastic residue could be identified in the cartridge that did not run the length of the cartridge, suggesting that an inadequate amount of ovd/bss may have contributed to the complaint and observed issues.The handpiece was disassembled and assembly was inspected.No issues were identified that could have contributed to to the complaint or observed issue.The lens was removed and cleaned revealing the trailing haptic was damaged.The complaint issues (cartridge crack and delivery issue) were not confirmed.The complaint issue (cartridge tip cracked/damaged) was confirmed.Based on the complaint investigation results the complaint issue and the observed issues could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.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 Key16820943
MDR Text Key314082806
Report Number3012236936-2023-01043
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474731752
UDI-Public(01)05050474731752(17)250903
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 05/31/2023
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 NumberDIB00
Device Catalogue NumberDIB00U0200
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 03/31/2023
Initial Date FDA Received04/26/2023
Supplement Dates Manufacturer Received05/10/2023
Supplement Dates FDA Received05/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2022
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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