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	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the preloaded intraocular lens (iol) model pcb00 did not advance completely out of the cartridge and iol was in patient right eye then removed.Procedure was completed using new lens of different model zcb00 but same diopter.There was no patient injury and patient is doing great post-op.No further information is available.
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 (b)(4).
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 8/28/2020.Device returned to manufacturer ¿ yes.Device evaluation: it was returned in a plastic bag.Plunger was in a fully advanced position and all the components were correctly engaged.There is no assembly error and /or defect observed related to manufacturing process.Visual inspection performed under microscope: lack of lubricant material residue was observed in the device.The lens returned out of the device and it looks in a good condition.No damaged/defect was identified in the product returned that may lead the reported conditions.The reported issues were not verified.Based in the analysis no product quality deficiency was identified.Manufacturing records review: the manufacturing records for the device were reviewed.There was no discrepancy and/or deviation found during the mrr (manufacturing record review).The product was manufactured and released according to specification.A search in complaint system revealed that no additional complaint was received from this production order.Conclusion: 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.

• 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: 10464025
• Report Number: 2648035-2020-00647
• Device Sequence Number: 14054442
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)230306
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 03/06/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/25/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/28/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005