MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC TECNIS; TORIC IOLS

Model Number	ZCT150
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.Serial number was not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens zct150 (diopter unknown) was implanted in the right eye (od) of the patient on (b)(6) 2018.The patient is post radial keratotomy (rk) with a three (3) diopter refractive surprise.Reportedly, the lens was explanted on (b)(6) 2018, and replaced with another lens (same model, +26.5 diopter).At 1-month post-op the patient uncorrected vision was 20/25.No further information was 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.In reviewing the file, section g7 in follow-up report #1, was inadvertently submitted with number 2 entered in this field, and follow-up #2, was inadvertently submitted with #3.Therefore, this supplemental report section g7 is populated with number 4, although this report is follow-up #3.
Additional Manufacturer Narrative
Corrected data: the previous supplemental mdr 9614546-2018-00696, follow up #1, was inadvertently submitted as follow up #2 in section g7 when it should have been indicated as follow up #1.Therefore, this follow up report is correctly the follow up #2, however in g7 it has been indicated as follow up #3 in order to electronically submit the report.Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer''s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Historical data analysis: the search in complaint history revealed that no similar complaints were received 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.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Additional info: additional information was received and it was learnt that the patient visual symptoms were first reported/noticed on (b)(6) 2018.The lens zct150 +29.5 diopter with serial number (b)(6) was explanted from the patient''s right eye and replaced with a zct300 +32,5 diopter.No incision enlargement, no vitrectomy was performed and no patient injury.The patient was reported doing well post-surgery with 20/25 uncorrected vision.No further information was provided.The following fields were updated: section a2.Date of birth: (b)(6) 1952 section a3.Sex/gender: female section b3.Date of event: (b)(6) 2018 section d4: serial #: 8348171610 section d4: catalog #: zct150u295 section d4: expiration date: 10/10/2020 section d4: udi #: (b)(4).Section h4: manufacturing date: 10/10/2016 all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Placeholder.
Additional Manufacturer Narrative
Corrected data: this report is being submitted as follow-up number one (1) for manufacturer report number 9614546-2018-00696.In review, what should have been follow-up #1 was inadvertently submitted with the number two (2) populated in section g6 type of report follow-up #.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7705338
• Report Number: 9614546-2018-00696
• Device Sequence Number: 1329465
• Product Code: HQL
• UDI-Device Identifier: 05050474552333
• UDI-Public: (01)05050474552333(17)201010
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 10/25/2020; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/12/2023; 08/06/2018; 09/06/2018; 11/06/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005