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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 Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2023
Event Type  malfunction  
Event Description
It was reported that the surgeon began inserting the tip of the inserter in the patient¿s right eye and while doing so, noticed that the lens had come out of the tip of the inserter.The surgeon was unable to proceed with using that lens for surgery as he was unable to get through the opening with an exposed lens.It was confirmed that there was patient contact with the device.It was indicated that the patient had a previous vitrectomy in the surgical eye, and it was noted that the eye was very soft.A backup lens of the same model and diopter was used, and the surgery was completed without further complications which no vitrectomy required, and no sutures were placed.It was confirmed that there is no medical/surgical intervention expected in the future either.No further information was provided.
 
Manufacturer Narrative
Section a4 and a5: unknown/ asked but not available.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.An attempt was made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
Additional information: additional information received from the customer indicated that the patient had a vitrectomy prior to the date of this surgery.It was noted that due to the prior vitrectomy the eye was soft, but this vitrectomy was not done at the customer's facility.The customer also confirmed that there were not capsule tears that were noted by the physician.Section d9: device available for evaluation: yes section d9: returned to manufacturer on: (b)(6) 2023 section h3: device evaluated by manufacturer: yes device evaluation: the complaint handpiece was received for evaluation.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod in an advanced position.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.No iol was received as part of this return.The complaint issue (uncontrolled delivery) was not confirmed and could not be confirmed to be related to a manufacturing or design issue.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 Key16892139
MDR Text Key314821869
Report Number3012236936-2023-01176
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474636132
UDI-Public(01)05050474636132(17)251112
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/06/2023
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 NumberDCB0000225
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 04/11/2023
Initial Date FDA Received05/08/2023
Supplement Dates Manufacturer Received05/12/2023
Supplement Dates FDA Received06/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2022
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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