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 Macular Edema (1822); Inflammation (1932); Blurred Vision (2137); Unspecified Eye / Vision Problem (4471)

Event Type  Injury  

Manufacturer Narrative

Section b3: date of event: unknown/not provided.Only provided as two weeks after surgery.Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section e1: telephone number: (b)(6).Section h3-other (81): the device was not returned 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.Attempts have been made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a patient with an eyhance intraocular lens (iol) is unhappy with her iol as she is experiencing higher order aberrations (hoa) after surgery when there was almost none prior to the iol implant.Prior to surgery her refraction was -1.00 -1.00 x 73 20/60 post surgery refraction is +0.50 -1.00 x 067 20/25.The patient is stating that the right eye is not crisp, fells like a film over the right eye, can see the letters but image is blurry.The autorefraction on (b)(6) 2023 shows +0.50 -0.75 x 50.There is no tilt or edema and patient has minimal astigmatism post surgery.There may be a need to explant the iol.Through follow up, it was learned that the patient reported vision was crisp for two weeks after surgery and then became blurry and unclear.On (b)(6) 2023, patient stated not being able to see the dashboard, cannot see the phone clearly, and the tv is not clear, images are blurry.Patient had operative (op) inflammation, symptoms starting (b)(6) 2023 and was seen (b)(6) 2023.Patient was prescribed drops and was healed by (b)(6) 2023.Cme (cystoid macular edema) was observed on (b)(6) 2023 and patient was prescribed drops.Cme resolved on (b)(6) 2023.No other medical interventions reported.It was also confirmed that the iol exchange has not been scheduled as of yet.The lens remains implanted at this time.No other information was provided.

• 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: 18871075
• MDR Text Key: 337293610
• Report Number: 3012236936-2024-00648
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655430
• UDI-Public: (01)05050474655430(17)250916
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: DIB00I0215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White