MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

Model Number AR40E

Device Problem Defective Device (2588)

Patient Problems Nausea (1970); Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)

Event Date 11/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that patient was experiencing blurry vision after the implantation of model ar40e monofocal iol (intraocular lens).Further examination done by the doctor revealed that the lens was found to be blurry.As a result, the lens was explanted and replaced with non-johnson & johnson product.Through follow-up, there was no secondary intervention required such incision enlargement, suture, nor vitrectomy.No additional information provided.

Manufacturer Narrative

Additional information: based on new information received, the patient was admitted to the hospital (b)(6) 2018, due to fixed black shade sensation before the right eye after cataract surgery at another hospital 20 days ago.The patient complained of blurred vision without painful red eye, eye swelling, nausea or vomiting.He visited the hospital for re-examination, but the specific diagnosis and treatment were unknown.There was no special treatment provided.He was admitted to the outpatient clinic with a diagnosis of right eye intraocular lenticular opacities.He had been passable in spirit, good in sleep and appetite, and normal in defecation and urination since disease onset.Preoperative diagnosis: right eye oil opacities, right eye macular epiretinal membrane, left eye senile cataract brief medical examination of eyes: hyperemia eyelid and edema eyelid were not found.The conjunctival hyperemia was not found.Both corneas were transparent.The anterior chamber was normal/ decreased.Both pupils were round, same of the diameter of about 2.5 mm and the pupillary reflex was sensitive.The iol in the right eye (od) was located at proper site and diagonal bar gray opacity band was noted in the central optical site of iol.Lenticular opacities were noted in the left eye (os).Fundus oculi: gold-foil-like light reflex was found in right-sided macular region and left retina was normal.The intraocular pressure for both right and left side is 13mmhg.Surgical indications: 1.Iol opacities were found in which the black shade sensation before the eyes and it has impacted normal living.2.The patient could tolerate the operation after generalized auxiliary examination.Date of operation: (b)(6) 2018 - superficial anesthesia the following sections were updated accordingly: if explanted; give date: (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

In review of the file, it was noted that the udi number was inadvertently not provided.The following section has been updated accordingly: udi#: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: the intraocular lens was not returned.Therefore, an investigation could not be performed and the customer's reported event could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints revealed that one other complaint has been received for this production order number.However, it is unrelated to this complaint.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: SENSAR
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8259609
• MDR Text Key: 133462604
• Report Number: 2648035-2019-00097
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR