MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU375
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4, and a5: unknown; requested but not provided.Section b3: date of event: unknown; requested but not provided.The best estimate date is prior to (b)(6) 2024.Section d4: model number: unknown; requested but not provided.Section d4: serial number: unknown; requested but not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section h3 - other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that three johnson and johnson intraocular lenses (iols) did not work right.No further information was provided.This report is to capture the second lens event.Separate reports will be submitted to capture the first and third lens event.
Additional Manufacturer Narrative
Additional information: through follow-up, it was reported that during implantation of the non-preloaded intraocular lens (iol), there was difficulty with the right eye and lens and the patient needed a capsular tension ring.It was noted there was zonular weakness.The lens fully inserted and then removed and replaced in the same procedure.Another johnson and johnson lens was implanted as replacement (zcb00, 26.5 diopter) and intravenous diamox was given.The event date was (b)(6) 2023.Directions for use was followed.There was a 45-minute delay in procedure.No incision enlargement, vitrectomy, or suture was required.The device model and serial number, patient gender, date of birth and age, race, weight, and the surgeon¿s name and phone number were also provided.No further information was provided.Correction: based on the additional information received, there is no indication that the lens was damaged, as initially reported, therefore, section h6: medical device problem code 1069 ¿ break, is no longer applicable.The event was originally reported as a reportable malfunction, however, based on the additional information received, the event has been changed to a reportable serious injury.Based on the additional information received, multiple fields are being corrected from what was reported on the initial report.Therefore, this supplemental report is capturing this new and corrected information.The following fields have been updated/corrected accordingly: section a2: date of birth: (b)(6) 1939 section a2: age: 83 years.Section a3: gender: female.Section a4: patient weight: 223 pounds.Section a5: race: white.Section b1: report type: adverse event.Section b2: outcomes attributed to adverse event (check all that apply): required intervention to prevent permanent impairment/damage (devices).Section b3: date of event: (b)(6) 2023.Section d1: brand name: tecnis iol.Section d4: model number: zcu375.Section d4: catalog number: zcu375u270.Section d4: serial number: (b)(6).Section d4: expiration date: nov 4, 2024 section d4: unique identifier (udi) number: (b)(4).Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d11: concomitant medical product: 1mtec30, cm36311.(b)(6).Section h1: type of reportable event: serious injury.Section h3 - other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: nov 4, 2019.Section h6: health effect - impact code 4631 ¿ more complex surgery.Section h6: health effect - impact code 4632 ¿ prolonged surgery.Section h6: health effect - impact code 4644 ¿ medication required.Section h6: health effect - clinical code 4581 ¿ appropriate term / code not available ¿ to capture eye anatomy issue.Section h6: medical device problem code 2993 ¿ adverse event without device or use problem.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18784686
• Report Number: 3012236936-2024-00491
• Device Sequence Number: 18228755
• Product Code: HQL
• UDI-Device Identifier: 05050474700703
• UDI-Public: (01)05050474700703(17)241104
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2024
• Device Model Number: ZCU375
• Device Catalogue Number: ZCU375U270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30, CM36311
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Race: White