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

Model Number AR40E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Stromal Edema (1824); Intraocular Pressure Increased (1937); Visual Impairment (2138); Vitreous Detachment (2445); Capsular Bag Tear (2639); Eye Pain (4467)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.Section d6b: explant date: not applicable, as lens was not explanted.Section e1: initial reporter telephone number: (b)(6).Section h3-other (81): the device is not returning for evaluation as to date it remains implanted; 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.

Event Description

It was reported that patient received intraocular lens implantation for cataract surgery of right eye under topical anesthesia due to senile cataract of eyes.There was vitreous spillage caused by anterior lengthening and laceration of the sac.During the anterior vitrectomy, the patient had pain and increased intraocular pressure.During the 3 days post operation slit lamp examination it was found choroidal detachment and the postoperative visual acuity was observed.Patient's postoperative visual acuity had a great impact.Additional information was received that anterior haptic of intraocular lens ruptured the posterior capsule when the intraocular lens was implanted during the surgical operation, resulting in vitreous spillage and subsequent choroidal detachment.No further information available.

• 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: 18097532
• MDR Text Key: 327696760
• Report Number: 3012236936-2023-02799
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502147
• UDI-Public: (01)05050474502147(17)250416
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: AR40E00220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2020
• 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): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female