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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2020
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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a dcb00 model intraocular lens could not be advance the at first and finally when lens was advanced the surgeon did not like the way the lens looked.There was no patient contact, patient injury or medical interventions were required.No further information available.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes section d10: returned to manufacturer on: 1/25/2021 section h3: device returned to manufacturer: yes.Device evaluation: the product was returned in its original packaging.Upon evaluation the plunger was in a fully advanced position.All the components were correctly engaged, and the plunger was centered.No assembly error and/or defect related to manufacturing process were observed.Traces of lubricant material residues were observed in the device.The lens was received outside the device attached to adhesive tape and the haptics look slightly distorted.Also, the tip of cartridge was damaged/deformed.The conditions observed are associated to handling.Due to the condition of the sample returned the reported issue was not verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.There are no discrepancies found during the mrr (manufacturing record review).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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY 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: 11061277
• Report Number: 2648035-2020-00956
• Device Sequence Number: 16790645
• Product Code: HQL
• UDI-Device Identifier: 05050474636002
• UDI-Public: (01)05050474636002(17)230827
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 08/27/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/13/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1