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

Model Number	ZCB00
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: this event was initially included in vmsr filing 2648035-2021-00007.Due to the inclusion of other ancillary details that may appear as causes in the vmsr filing, this event is now being captured as an initial 30 day mdr.This report captures the event for serial number (b)(4).This is report number 3 out of 12 reports that are being submitted as initial individual mdrs.Implant date: if implanted, give date: not applicable iol was not implanted.Explant date: if explanted, give date: not applicable iol was not explanted.Device evaluation: the original folding carton (with customer notes) was received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptic and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.Conclusion: 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) lens surface was defective.Lens was implanted and removed from the patient's right eye during the same procedure using a same model and diopter lens.Additional information was provided that the lens was defective.There was a gouge in the center of the lens surface, therefore, it was removed from the patient's eye.The patient is reported to be doing fine.No other information was provided.

• Brand Name: TECNIS 1-PIECE
• 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: 12164153
• Report Number: 2648035-2021-00044
• Device Sequence Number: 14466158
• Product Code: HQL
• UDI-Device Identifier: 05050474531567
• UDI-Public: (01)05050474531567(17)221008
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/13/2021

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: 10/08/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE UNKNOWN MODEL AND LOT#
• Patient Age: 74 YR