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	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.(b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the plunger of preloaded intraocular lens went past the lens, so the partially delivered lens had to be ejected from the eye again.No intervention necessary, another lens was implanted as replacement lens for the patient.There were no further complications.No further information 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: section d10: device available for evaluation ¿ yes, returned to manufacturer on 2/14/2020 section h3: device returned to manufacturer ¿ yes device evaluation: the complaint product was returned in its original packaging.The plunger was observed in a fully advanced position.Cartridge was correctly engaged to the device.No assembly error or defect related to the manufacturing process was observed.Visual inspection performed under microscope magnification: small amount of lubricant residues can be observed in the device.The lens was stuck at the cartridge tip and pushrods overrides it.The reported issues were verified.Therefore, due to the conditions in which the sample returned it is not possible to determined that the reported issues are related to the manufacturing process.Based in the analysis 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.A search 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.All pertinent information available to johnson and 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: 9771372
• Report Number: 2648035-2020-00197
• Device Sequence Number: 19563498
• Product Code: HQL
• UDI-Device Identifier: 05050474557963
• UDI-Public: (01)05050474557963(17)211031
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 10/31/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/02/2020; 10/25/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/29/2020; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005