MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXW300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from a patient's left eye due to refractive surprise, myopic surprise and iol malrotation.It was indicated that on (b)(6) 2024, the numbers looked suspicious but since it was 1-day post-op, they decided to wait longer.Then on (b)(6) 2024 they noticed the patient's issue.The rotation was less than 10 degrees.The replacement lens was of the same model, but lower diopter (17.5d).There were no medical or surgical interventions required and no patient injury or complications such as capsule tear reported.The patient outcome on (b)(6) 2025 was reported to be -1, -0.5, 140, uncorrected visual acuity (va) 20/50, which is worse than what the patient should have been, worse myopic than what it was with the original lens.No further information was provided.
Additional Manufacturer Narrative
Section a4.Weight: unknown, information was requested but not provided.Section b3: date of event: unknown/not provided, but the best estimate date is between (b)(6) 2024 (1-day post-op) and (b)(6) 2024.Section h3(no): the device was not returned for evaluation; 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 the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information/corrected data: additional information received from doctor which the following fields were updated or corrected accordingly: section a2: date of birth: (b)(6).Section b3: date of event: on 11/22/2024, the numbers looked suspicious but for one day post-op, they decided to wait longer.Then on (b)(6) 2024 they noticed the patient's issue.Section d5: the replacement lens was of different cylinder and lower diopter (zxw225 +17.5).It was indicated that the rotation was about 5 degrees.The patient outcome was reported as still pending.At post op week-1, the patient was 20/50 uncorrected with a manifest refraction of -1.00 -0.50 x 140 (corrected to 20/25-) all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information indicated that the patient had myopic surprise and astigmatism over-correction with the original lens.With the original lens, the patient's autorefraction was -0.50 -0.50 x 139, the manifest refraction was -1.00 -0.50 x 140, and the cycloplegic refraction was +0.25 -1.50 x 155.Hope this answers your questions.No debilitating condition reported with the patient.The iol has been exchanged and the patient is doing well 1 month after surgery.The replacement lens is zxw225 +17.5 diopter (sn (b)(6)).No further information provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review of the event and based on the additional information provided, since the replacement lens is of a different cylinder (zxw225) than that of the original lens (zxw300) and as reported that the patient is doing well 1-month after surgery; therefore, the event no longer meets a reportable explant criteria and no further report will be submitted under this manufacturer report number 3012236936-2025-0000145.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21164599
• Report Number: 3012236936-2025-000014
• Device Sequence Number: 19896550
• Product Code: POE
• UDI-Device Identifier: 05050474733497
• UDI-Public: (01)05050474733497(17)251014
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2025

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: 10/14/2024
• Device Model Number: ZXW300
• Device Catalogue Number: ZXW300U180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 02/11/2025; 03/04/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/10/2025; 03/10/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2020
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White