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

Model Number	DXW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient experienced blurry distance and near vision following the full implantation of a single-piece preloaded toric edof intraocular lens (iol) in the patient¿s right eye.The original lens was subsequently explanted during a secondary surgery on the same day.Preoperative best-corrected visual acuity (bscva) was 20/20, and postoperative bscva remained 20/20.Daily activities were not affected.No unplanned surgical interventions, such as incision enlargement, sutures, or vitrectomy, were required.No medications outside the standard of care were prescribed, and no surgical delays were reported.The directions for use were followed.The patient experienced temporary bilateral visual impairment.Additional information was received on the patient's right eye.The device was reported to have caused or contributed to the event, and the patient was noted to be under-corrected with no loss of two or more lines of best spectacle corrected visual acuity and no overcorrection.The pre-operative refraction was +0.25 -1.00 x 130 with a post-operative refraction of +0.75 sphere and an intended target refraction of plano.A pre-existing condition affecting calculation was lasik.The original iol was replaced by a preloaded extended depth of focus intraocular lens with a diopter of +21.However, post-operative refraction after the lens exchange had not yet been measured.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Device evaluation: visual inspection revealed that the lens was cut into three pieces.The lens was cleaned and visually inspected revealing no further issues or that could cause or contribute to the complaint issues reported were identified during product evaluation.The lens cut observed during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.The following fields were updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 18, 2026.Section h3: device evaluated by manufacturer: yes.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco 00610 ; 7142478552
• MDR Report Key: 24742009
• Report Number: 3012236936-2026-000074
• Device Sequence Number: 19693923
• Product Code: HQL
• UDI-Device Identifier: 05050474762978
• UDI-Public: (01)05050474762978(17)260813
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 04/28/2026

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 Model Number: DXW150
• Device Catalogue Number: DXW150U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2023
• 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: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White