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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 Problems Premature Activation (1484); Failure to Eject (4010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2020
Event Type  malfunction  
Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that an intraocular lens (iol) ejected prematurely into the left eye.The lens was partially inserted and removed.There was no vitrectomy, incision enlargement or sutures required.Another johnson & johnson lens (same model and diopter) was implanted as a replacement.The patient is doing good post-operatively.No other information provided.
 
Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 10/12/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the pcb00 preloaded insertion system unit was received in its original box.The cartridge component was observed correctly engaged into lower body of the pcb00 device.The lens returned broken and out of the pcb device.One part of the lens including the haptic was observed detached.The plunger component was observed in a fully advanced position.Visual inspection using microscope magnification was performed.Residues of lubricant were observed at the cartridge tube.Also, at the lens surface.The condition observed is consistent with preloaded unit used.No manufacturing defects were detected.The reported issue could not be confirmed on the return.No product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.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.
1700 e st andrew place
santa ana CA 92705
MDR Report Key10571508
MDR Text Key208107716
Report Number2648035-2020-00706
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474558298
UDI-Public(01)05050474558298(17)220911
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/24/2020
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 Expiration Date09/11/2022
Device Model NumberPCB00
Device Catalogue NumberPCB0000215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/23/2020
Supplement Dates Manufacturer Received10/29/2020
Supplement Dates FDA Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age81 YR
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