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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iol subluxated posteriorly as it was implanted in the sulcus.The lens was fully inserted into the patient's eye.The patient's pre-operative visual acuity for the left eye was 1/60 1/60 and the post-operative visual acuity for right eye was 6/40, 6/30.There were vitrectomy and sutures performed.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 d6b: explant date: there is no information that explant has been done.Section e1: initial reporter first & last name: unknown/information not provided.Section e1: email address: unknown/not provided, as information was asked but it was 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, 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
Additional information was received.Because of this, the previously reported information needs to be updated and corrected.Sectio b5 - describe event/problem: it was reported that the iol had a positioning issue and was subluxated posteriorly as it was implanted in the sulcus.There was haptic kinking.The lens was fully inserted into the patient's eye.The patient's pre-operative visual acuity for the left eye was 1/60 and post-operative visual acuity for the left eye was 6/30, and the pre-operative visual acuity for right eye was 6/45 and post-operative visual acuity for right eye was 6/30.There were unplanned vitrectomy and sutures performed.There was no delay in treatment or other interventions performed.No further information was provided.Section h6 - medical device problem code: 1069 - break.1316 - difficult to insert.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the iol had a positioning issue and was subluxated posteriorly as it was implanted in the sulcus.There was haptic kinking.The lens was fully inserted into the patient's eye.The patient's pre-operative visual acuity for the left eye was 1/60 and post-operative visual acuity for the left eye was 6/30, and the pre-operative visual acuity for right eye was 6/45 and post-operative visual acuity for right eye was 6/30.There were unplanned vitrectomy and sutures performed.There was no delay in treatment or other interventions performed.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: 17932023
• Report Number: 3012236936-2023-02515
• Device Sequence Number: 12362604
• Product Code: HQL
• UDI-Device Identifier: 05050474502109
• UDI-Public: (01)05050474502109(17)280310
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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: Other; Required Intervention
• Patient Sex: Male