MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. TECNIS IOL; Intraocular Lens

Model Number	DXW150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Contracture (1761); Uveitis (2122); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported that following implantation of a preloaded multifocal intraocular lens (iol), model dxw150, the patient experienced halos, and a postoperative flipped axis was observed.Due to these symptoms, the implanted lens was explanted during a secondary surgical procedure and replaced with a zcb00 21.5 d iol (sn (b)(6)).Additional follow-up information indicated that the patient was a glaucoma suspect in both eyes (ou) and had previously undergone cataract surgery with implantation of a toric extended depth of focus (edof) iol and a kahook dual blade (kdb) procedure in the left eye (os).The postoperative course was complicated by significant visual distortions and ugh (uveitis-glaucoma-hyphema) syndrome in the left eye, which necessitated an iol exchange procedure.Intraoperative findings during the lens exchange revealed that the toric iol was positioned at the 108-degree meridian, with the trailing haptic located in the sulcus.Fibrosis of the inferior capsule was also noted.The patient's ocular history was significant for dry eye syndrome and myopia.The patient's medical history included insomnia, depression, and attention-deficit/hyperactivity disorder (adhd).At the time of follow-up, the patient was being treated with brimonidine ophthalmic solution in both eyes twice daily, cosopt in both eyes twice daily, and prednisolone ophthalmic suspension in the left eye four times daily.The expected postoperative refraction according to veracity was -0.10 -0.07 × 018; however, the actual postoperative refraction was +0.50 -0.50 × 111.The physician reported that the patient would continue treatment with brimonidine and cosopt and undergo follow-up glaucoma evaluation in nine months.Postoperative management following the iol exchange included moxifloxacin and prednisolone ophthalmic drops administered four times daily, continuous eye protection, activity restrictions including avoidance of heavy lifting and bending, and a follow-up clinic visit scheduled for one week postoperatively.No additional information was provided.
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is between may 26, 2026 and july 6, 2026.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.Section h6: health effect-impact code:4619-temporary impairment (dysphotopsia - (requiring surgical or medical intervention) and halo vision - (requiring surgical or medical intervention).Attempts has been made to obtain missing information; however, the information has not been provided.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 ; 31 technology drive; irvine, CA 92618 ; +1(714)247-8552
• MDR Report Key: 50100788
• Report Number: 3012236936-2026-000227
• Device Sequence Number: 21340331
• Product Code: HQL
• UDI-Device Identifier: 05050474763005
• UDI-Public: (01)05050474763005(17)260624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2026
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U215
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2023
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 172 LB
• Patient Race: White