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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS Back to Search Results
Model Number PCB00
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2018
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information 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.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.
 
Event Description
It was reported that the surgeon noticed that the intraocular lens (iol) was torn when inserting into the eye.No extra steps or enlarging of incision was warranted.Reportedly the lens was removed from patient¿s operative eye and another lens (same model) was implanted without issues.No patient injury reported and the patient was doing good when discharged.No further information provided.
 
Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 5/23/2018.Device returned to manufacturer ¿ yes.Device evaluation: the preloaded device was returned to the manufacturing site for evaluation.The plunger was observed in a fully advanced position and locked.The cartridge was correctly engaged into the device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection at microscope magnification was performed.The pushrod was exposed out of the cartridge tip.Lack of lubricant material was observed in the device.There was no lens received in or out of the device.The reported issue of iol torn could not be verified.However, the condition in which the sample was received is consistent with a unit that has been previously handled and prepared for surgical process.Based on the analysis there is no indication of product quality deficiency.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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Brand Name
TECNIS ITEC PRELOADED 1-PIECE IOL
Type of Device
MONOFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key7521104
MDR Text Key108488326
Report Number2648035-2018-00721
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474558298
UDI-Public(01)05050474558298(17)201226
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 faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/29/2018
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 Physician
Device Expiration Date12/26/2020
Device Model NumberPCB00
Device Catalogue NumberPCB0000215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/17/2018
Initial Date FDA Received05/17/2018
Supplement Dates Manufacturer Received06/04/2018
Supplement Dates FDA Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2017
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 Outcome(s) Required Intervention;
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