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

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section d-6a date implanted: future date on (b)(6) 2024 was provided as the answer.Section d-6b date explanted: not applicable as the iol was removed and replaced during the same procedure; therefore, not explanted.Section e-1 reporter telephone number: (b)(6) field only accepts the us phone number format.Section h-3 device evaluated by manufacturer: 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, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Chromatic aberration was reported by the physician following the implantation of the pre-loaded dcb00 model intraocular lens (iol).Patient stated she sees colors different from the original, product is red she sees green.The iol was removed and replaced during the same procedure, information about the replacement iol is unknown.There are no daily activities that the patient cannot perform that she was able to prior to the surgery.During the procedure, there was no incision enlargement, sutures, vitrectomy, medication prescribed (outside of standard care), and no medical attention was required.The iol directions for use were followed.Both completely recovered and unknown were provided as answers for patient status.The suspect iol is not available for return as it remains implanted.No further information is available.

• Brand Name: TECNIS SIMPLICITY
• 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: 20349473
• Report Number: 3012236936-2024-000268
• Device Sequence Number: 8000289
• Product Code: HQL
• UDI-Device Identifier: 05050474636217
• UDI-Public: (01)05050474636217(17)251206
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000265
• 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: 09/10/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2022
• 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 Sex: Unknown