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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 04/18/2023
Event Type  malfunction  
Event Description
It was reported that as the surgeon was positioning the inserter to place the lens into the patient¿s right eye, he advanced the intraocular lens (iol) and the lens ejected into the anterior chamber, and the surgeon was unable to maneuver it into the bag.The surgeon stated that he did not feel as though he was engaging the inserter to cause the early ejection of the iol.There was patient contact.Reportedly, the iol was removed, and a backup lens of the same model and diopter was implanted.There were no adverse events, no injury and no other medical intervention was required.It was indicated that the patient is doing well.No further information was provided.
 
Manufacturer Narrative
Unknown, information was requested but not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section h3: other 81: the device was not returned for analysis.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, to date, no response has been received.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: date returned to manufacturer: may 15, 2023 section h3: 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 the 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.Visual inspection of the complaint lens revealed that it was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or contribute to the complaint issue were identified.The complaint issue could not be confirmed during product evaluation, and no issues were identified.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 Key16916156
MDR Text Key315369848
Report Number3012236936-2023-01202
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474636057
UDI-Public(01)05050474636057(17)260121
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 06/01/2023
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 NumberDCB0000185
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 04/19/2023
Initial Date FDA Received05/11/2023
Supplement Dates Manufacturer Received05/19/2023
Supplement Dates FDA Received06/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2023
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 SexFemale
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