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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: date of birth, age, weight, ethnicity and race: unknown/ not provided.Section d6a: na as the lens was removed/replaced during the same procedure.Section d6b: na as the lens was removed/replaced during the same procedure.Section e1: last name and email address: unknown/ not provided.Section e1: telephone number: (b)(6).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the lens haptic was kinked permanently.Upon implantation of non-preloaded monofocal intraocular lens (iol) into the patient's eye.The patient was temporarily impaired.The lens was fully inserted and removed during the same procedure.T here was sutures, incision enlargement and medications being prescribed to the patient.There was delay in treatment of 1 hour and no other interventions performed.Directions for use were followed.No further information was provided.

• Brand Name: SENSAR 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: 18398909
• Report Number: 3012236936-2023-03235
• Device Sequence Number: 19507894
• Product Code: HQL
• UDI-Device Identifier: 05050474502048
• UDI-Public: (01)05050474502048(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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: 11/30/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00170
• 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: 12/04/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2018
• 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