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	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, the lens was not implanted.If explanted, give date: not applicable, the lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a pcb00 preloaded intraocular lens (iol) was partially inserted into the patient's right (od) eye on (b)(6) 2020.The lens would not advance in the preloaded inserter while inserting.The procedure was completed successfully with a back up lens of the same model.There was no surgical intervention performed during the replacement process.The current patient status was reported as recovered.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
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 3/16/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was received with packaging components (folding carton) and pcb00 device.A visual inspection using magnification was performed to device sample returned and the following were the observations: the plunger and pushrod was observed in advanced position.Viscoelastic residues of lubricant material were observed on cartridge.The lens was out of the device, and one of the haptic was detached.The cartridge tip was observed in good conditions.The complaint issue was verified.Based on the visual evaluation of the returned unit it could not be determined that the cause of the issue reported is related to the manufacturing process since there are indications the unit was handled and prepared for lens insertion at the surgical stage.A product quality deficiency 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 of complaints revealed no additional compliant were received from this production order.Conclusion: as a result of the investigation there is no indication of a quality product 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: 9858529
• Report Number: 2648035-2020-00268
• Device Sequence Number: 19563394
• Product Code: HQL
• UDI-Device Identifier: 05050474557987
• UDI-Public: (01)05050474557987(17)210702
• 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: 07/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 10/25/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/09/2020; 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: 34 YR
• Date Report Sent to FDA: 01/01/2005