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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that an intraocular lens (iol) was partially inserted into the patient's right eye, it failed to deploy the lens into the loader.There was no indication of patient injury, or that medical or surgical intervention was required.A new lens was implanted.No additional information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly.Section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 03/10/2020.Section h-3 device returned to manufacturer: yes.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection at microscope magnification was performed and scarce amount of viscoelastic were observed at the cartridge.Directions for use (dfu) states to completely fill the viewing window of the pcb00 lens with ophthalmic viscosurgical device (viscoelastic).The cartridge was observed with residues of lubricant and the lens was observed stuck in cartridge and override.The reported issues were verified but it could not be determined if the condition observed is related to manufacturing process as the reported device was handling and use in a surgical procedure.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9767733
• Report Number: 2648035-2020-00189
• Device Sequence Number: 11493306
• Product Code: HQL
• UDI-Device Identifier: 05050474558212
• UDI-Public: (01)05050474558212(17)221024
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 10/25/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/10/2020; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005