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

Model Number	Z9002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using microscope magnification was performed: the returned z9002 tecnis sample was received with the lens cut and a haptic damaged.The z9002 tecnis device was observed under microscope and residues of viscoelastic were observed on the lens.The condition observed is consistent with a lens that has been explanted.The complaint issue reported as iol torn was not confirmed and due the condition of the z9002 tecnis received the complaint could not be related to the manufacturing process it could be related to the handling process; therefore, a product quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the review.The product was manufactured and released according to specifications.The search revealed that no other complaint has been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens was cracked.There was patient involvement.No incision enlargement, no vitrectomy, no sutures were required.This was observed while inserting the lens into the eye.Additional information was received, and it was learnt that the lens was fully inserted, removed and replaced in same surgical procedure without any patient injury.Reportedly lens with same model and diopter was used as replacement for the patient.Patient was doing great at discharge.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 nr-0148919 and capa-010215.

• Brand Name: TECNIS CL
• 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: 8368723
• Report Number: 2648035-2019-00233
• Device Sequence Number: 1620158
• Product Code: HQL
• UDI-Device Identifier: 05050474530713
• UDI-Public: (01)05050474530713(17)220626
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 11/09/2020
• 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: 06/26/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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: PCST30 LOT# UNKNOWN
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005