MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

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

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021.Explant date: lens remains implanted; therefore, not explanted.(b)(6).The intraocular lens (iol) 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, labeling, 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.Attempts were made to obtain the missing information; however, the information was not available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that in (b)(6) 2021, a patient had an eyhance intraocular lens (iol) implanted in both eyes.The target refraction was emmetropia with slight monovision.Patient has had several regular doctor's visits due to experiencing temporal, crescent-shaped, pulsating shadows more so in the left eye than the right.Patient's daily activities are significantly impacted as patient provided being severely disturbed.Account indicated that the shadow on the left eye partially extend into the visual center; therefore, restricting the patient so much that they have trouble at work.The doctor's best diagnosis is negative dysphotopsia.The refraction was at the exact targeted values of -0.11 for the right eye and -0.44 for the left eye.Patient was given maxidex 4 times a day for a total of 4 weeks as part of the normal standard of care.The lenses remain implanted.No further information was provided.This report is being filed for the patient's left eye.A separate report is being filed for the patient's right eye.

• Brand Name: TECNIS SIMPLICITY
• 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: 13122762
• MDR Text Key: 286328612
• Report Number: 3012236936-2021-00382
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655478
• UDI-Public: (01)05050474655478(17)240514
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00I0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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
• Patient Sex: Male