MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the non-preloaded extended range of vision intraocular lenses (iols) were implanted in both eyes, the patient initially could see well, but sometime in (b)(6) 2023 the patient stopped being able to see close up.The patient reported that the close up vision is blurred, even when not looking at anything.After putting on glasses, the patient can see up close again.The patient feels like something is in the eyes and it feels like the eyes are fuzzy when closed, like ¿they are going over something¿.The patient reported that the symptoms do not significantly interfere with daily activities.No medical or surgical intervention has been done for either eye and nothing is planned at this time.The patient has an appointment scheduled for (b)(6) 2023.Additional information was received from the patient on (b)(6) 2023 reporting that the patient visited the doctor on (b)(6) 2023 and was advised that the lenses are doing fine and are doing ¿what they are supposed to be doing¿.The patient was told the eyes are really dry and that the doctor was going to be performing a ¿laser treatment¿ on each eye.The dates of the scheduled laser procedures are (b)(6) 2023.Additional information was received from the patient on (b)(6) 2023 reporting that the surgeon performed a "laser" treatment on the right eye on (b)(6) 2023 and on the left eye on (b)(6) 2023.The patient was unable to provide the name of the laser treatment or what it was treating, the patient only reported having difficulty seeing close up and the surgeon said a laser treatment would be done for it.After the laser treatment was performed on both eyes, the patient reported still being unable to see clearly close up, as if there is a film over the eyes.The surgeon said to give it time and it will clear up.The patient reported still being able to do normal daily activities.If glasses are worn, the patient can see perfectly.The patient still feels like there is something in the eyes.The doctor did not provide any reason why this might be occurring nor any intervention for it, but advised that it should clear up.The surgeon wants to see the patient back in 6 months.There are no planned interventions at this time.No further information was provided.This report is to capture the left eye event.A separate report is being submitted to capture the right eye event.
Additional Manufacturer Narrative
Section b3: date of event: unknown; requested but not provided.The best estimate date is "sometime in (b)(6) 2023".Section d6b: if explanted; give date: not applicable, there is no indication the lens has been explanted.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s 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 specification.A search of complaints related to this production order (po) was performed.The search revealed that one other complaint for this po number has been received.Although these complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Based on the results, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received from the patient, reporting that the surgeon performed another laser procedure on both of the eyes, which occurred some time in (b)(6) 2023.The patient reported that it did not help, and the patient has still not gotten "any results," as glasses are still needed to see.The patient reported that the lenses are "not working" and only ¿worked¿ for a few months.No further information was provided.This supplemental report is for the left eye additional information.A separate supplemental report will be submitted for the right eye additional information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 17854099
• Report Number: 3012236936-2023-02445
• Device Sequence Number: 3390531
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)240129
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2024
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female