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

Model Number	DXW300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female section b-3 date of event: unknown/asked information was not provided.The best date estimation is may 2025.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section g1-2 manufacturer telephone number: (b)(6), (error message regarding format) device evaluation: product evaluation was not performed because the product has not been received; it remains implanted.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.The search revealed that no other complaints were received for this production order (po) number.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The dxw300 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).During a follow-up visit, a film was observed behind both lenses, which is a known occurrence in approximately 1 in 5 patients.The patient will require a laser procedure to address the accumulations.The lenses were noted to be in good condition.The patient later reported experiencing color distortion and blurry vision in both eyes starting in (b)(6) 2025, though these issues were not debilitating.An yttrium aluminum garnet (yag) laser procedure was performed on (b)(6) 2025.There was no incision enlargement, no serious patient injury, no sutures, and no vitrectomy.Patient prognosis post laser procedure was reported as full recovery with clear vision.The suspect iol is not available for return as it remans implanted.No further information is available.

• 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, puerto rico 00610
• MDR Report Key: 23885689
• Report Number: 3012236936-2025-000343
• Device Sequence Number: 20001491
• Product Code: HQL
• UDI-Device Identifier: 05050474765269
• UDI-Public: (01)05050474765269(17)250314
• 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: 2003
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2025
• Device Model Number: DXW300
• Device Catalogue Number: DXW300U165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2022
• 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
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White