MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. TECNIS IOL; Extended depth of focus intraocular lens

Model Number	DEN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an implanted extended depth of focus (edof) intraocular lens (iol) in the left eye (os) was associated with inadequate near and intermediate vision despite excellent distance visual outcomes.The reported visual difficulties impacted the patient's reading and work activities.The physician reported dissatisfaction with the lens performance and indicated that the lens had been explanted.The patient did not experience a loss of ¿2 lines of best spectacle-corrected visual acuity (bscva) and was not overcorrected or under corrected.Pre-operative refraction was reported as -3.00 -0.50 x 178 with a pre-operative bscva of 20/30+2.Post-operative uncorrected visual acuity (ucva) was reported as distance visual acuity (dva) 20/20 and near visual acuity (nva) j8.Post-operative refraction was +0.25 -0.25 x 053, with a post-operative bscva of 20/20 and an intended target refraction of +0.04.Post-operative findings reportedly suggested a questionable hyperopic target or landing.The explanted lens was exchanged for a non-johnson & johnson trifocal intraocular lens (iol) with a power of +15.0 diopters (d) and add powers of +1.75 d and +3.50 d.No additional unplanned or medical interventions were indicated.Following the lens exchange, the patient reported improvement in near vision and was satisfied with the outcome.Post-exchange distance visual acuity (dva) was reported as 20/25, and near visual acuity (nva) was j1, indicating excellent near vision.The explanted lens was not retained and is not available for return or evaluation.No further information was provided.This report is limited to the patient implanted with the lens model den00v, serial number (b)(6), who underwent lens explantation.The physician reported similar concerns in few patients; however, no additional explant events are included in this report.If additional explants are reported, separate mdr submissions will be made, as appropriate.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.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 intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.An attempt was made to obtain missing information; however, the information was not available.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 ; +1(714)247-8552
• MDR Report Key: 50136056
• Report Number: 3012236936-2026-000230
• Device Sequence Number: 14871366
• Product Code: POE
• UDI-Device Identifier: 05050474806344
• UDI-Public: (01)05050474806344(17)281222
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: DEN00V
• Device Catalogue Number: DEN00VU145
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2025
• 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: 74 YR
• Patient Sex: Male