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

Model Number AR40E

Device Problems Break (1069); Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2023

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 325626359
• Report Number: 3012236936-2023-02515
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502109
• UDI-Public: (01)05050474502109(17)280310
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male