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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the exact date is unknown, but it was stated that the issue happened (b)(6) 2019 if implanted; give date: n/a (not applicable).No patient involvement was reported.If explanted; give date: n/a (not applicable).No patient involvement was reported.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the lumen/tip of the cartridge was damaged and the intraocular lens didn't exit the delivery system.This happened during handling but prior to insertion into the eye.No patient involvement was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, date returned to manufacturer: 3/27/2019.Device returned to manufacturer: yes.Device evaluation: visual inspection using magnification was performed to the returned lens sample.The plunger and pushrod were observed in advanced position and the pushrod was observed to have overridden the lens in the cartridge.The lens was therefore observed stuck in cartridge.Residue of viscoelastic material was observed in the cartridge and the cartridge tip was deformed.However, the condition in which the returned lens was received is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported as cartridge damaged, stuck in cartridge and tip deformed were verified; but no product deficiency was found.Based on the returned product evaluation, a product quality deficiency or a product malfunction could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed no additional investigation requests for this production order number.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.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.
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.

• 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: 8420255
• Report Number: 2648035-2019-00334
• Device Sequence Number: 2228094
• Product Code: HQL
• UDI-Device Identifier: 05050474558182
• UDI-Public: (01)05050474558182(17)210702
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: PCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/05/2019; 10/25/2020
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/04/2019; 11/11/2020
• 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