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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was undergoing a planned scleral fixated secondary intraocular lens (iol) implantation procedure in their left eye.When the iol was introduced into the anterior chamber of the patient's eye, the trailing haptic broke.The iol was removed and replaced with a non-johnson&johnson lens.There were medications prescribed as part of standard of care, and planned sutures were placed.Account indicated that the patient was well post-operatively and vision was okay.There was no delay in treatment or other interventions performed.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Section d6a: implant date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: explant date: not applicable, as lens was removed/replaced in the initial surgery.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, 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 will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Product information was inadvertently submitted incorrectly in the initial report.Therefore, the following fields are being updated to reflect the correct information: additional information: section d1 - brand name: sensar iol.Section d2b - device product code: hql.Section d4 additional device information.Model number: ar40e.Catalog number: ar40e00225.Serial number: (b)(6).Expiration date: may 18, 2027.Primary unique device identification (udi) number: (b)(4).Section h4 - device manufacture date: may 19, 2022.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 17864749
• Report Number: 3012236936-2023-02463
• Device Sequence Number: 12280274
• Product Code: HQL
• UDI-Device Identifier: 05050474502154
• UDI-Public: (01)05050474502154(17)270519
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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 Model Number: AR40E
• Device Catalogue Number: AR40E00225
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female