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

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.

• 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 Key: 10571508
• MDR Text Key: 208107716
• Report Number: 2648035-2020-00706
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558298
• UDI-Public: (01)05050474558298(17)220911
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• 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 Date: 09/11/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR