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 Problems Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

Section a4, a5: unknown/ not provided.Asku.Section b3: date of event: the exact date is unknown, not provided.Best estimate of date of event is between (b)(6) 2023.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3-other (81): the device was not returned for evaluation as the lens 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.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a female patient who had cataract surgeries and was implanted with tecnis simplicity eyhance lenses in both eyes has been experiencing blurry and double vision in both eyes at distant, intermediate and close range.That "nightsky" stars are irregular ¿blobs¿, not pinpoints and the outer edges of her pupil/eyeball feel like there¿s something there.These symptoms have negatively affected her quality of life and activities of daily living.Reading is difficult and highway driving is not possible.Per her surgeon's recommendation - she had yttrium-aluminum-garnet (yag) laser procedure on her right eye to no effect.The progressive lenses prescribed are also not helpful in correcting these issues.No other information was provided.This report is for the left eye of the patient.A separate report will be submitted for the right eye of the patient.

• 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: 18460974
• MDR Text Key: 332263081
• Report Number: 3012236936-2024-00057
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: DIB00U0210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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 Age: 63 YR
• Patient Sex: Female