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

Model Number	PCB00
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during 2018.If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that model pcb00 tecnis monofocal iol (intraocular lens) was defective.There was no patient involvement, the iol was not used.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 01/29/2019.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system, model pcb00, was returned at the manufacturing site for evaluation.The plunger was observed in advanced position.The plunger was gently pulled back and found locked.Visual inspection under the microscope showed no trace of viscoelastic and/or balanced salt solution in the cartridge.The pcb00 cartridge was observed with stress marks at the tip.The dfu (directions for use) states to completely fill the viewing window of the pcb00 with ovd (ophthalmic viscosurgical device).There were no damages observed.The intraocular lens (iol) was not returned therefore an evaluation was not possible.The customer''s reported issue could not be verified.No product quality deficiency was identified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 and johnson surgical vision, inc.Has been submitted.
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 nr-0148919 and capa-010215.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8186556
• Report Number: 2648035-2018-01643
• Device Sequence Number: 1902644
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)200609
• Combination Product (Y/N): Y
• Initial Reporter Country: ES
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 06/09/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 02/07/2019; 10/25/2020
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/11/2019; 11/05/2020
• 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