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 Conjunctivitis (1784); Red Eye(s) (2038); Excessive Tear Production (2235)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Unknown/ not provided.Implant date: unknown, information not provided.Explant date: not applicable, as lens was not explanted.City: unknown/not provided.State, province, or territory: unknown/not provided.Post office or zip code: unknown/not provided.Telephone number: (b)(6).The device is not returning for evaluation as 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 had intraocular lens (iol) implant in the right eye.Two weeks later, the patient returned due to redness and lacrimation (tearing) in the right eye.Examination showed mild conjunctival congestion in the right eye, weakly positive ciliary tenderness, flocculent exudates in front of the anterior chamber intraocular lens, and sluggish light reflex.Medication was prescribed.Atropine eye gel eye drops three times a day; subconjunctival injection of dexamethasone injection 2.5 mg once; tobramycin dexamethasone eye drops three times a day; tobramycin dexamethasone eye ointment once every night.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: 14018360
• MDR Text Key: 293843287
• Report Number: 3012236936-2022-00878
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502154
• UDI-Public: (01)05050474502154(17)240930
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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: AR40E00225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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 Sex: Female