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

Model Number AR40E

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

Patient Problems Edema (1820); Blurred Vision (2137); Burning Sensation (2146)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, information not provided.Catalog#: unknown, as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Serial#: unknown, not provided.Unique identifier: unknown, as the serial number was not provided.Explant date: not applicable, there is no indication the lens has been explanted.Device manufacture date: unknown, as the serial# was not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: 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.

Event Description

It was reported that a model ar40e intraocular lens (iol) was implanted into the patient's left eye.Additionally, a piggy back lens is also implanted.The doctor reported that their patient experienced unexpected post-op refraction.During their post-op checkup, the patient's mr (manifest refraction) was -19.0 20/800 not clear.Reported symptoms are pseudophakia, myopia, astigmatism, blurry vision, and burning sensation.The doctor also reported edema peripherally.The eye lid was normal, and the pupil was irregular and sluggish.No relative afferent pupillary defect (rapd) noted.Both iols were in a good position.Reportedly the patient had no discomfort and his visual acuity slightly improved.The patient was prescribed gatifloxacin and prednisolone.No further information was provided.

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 nr-0148919 and capa-010215.

• Brand Name: SENSAR
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9114516
• MDR Text Key: 160911818
• Report Number: 2648035-2019-01037
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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: AR40E
• 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: 30 YR