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	Discomfort (2330)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from patient's left eye as the patient was unhappy with distant vision.The lens was explanted in a secondary procedure and replaced with a drt lens.There was no patient injury.There was no medical/surgical intervention required.The patient is doing well.No other information is available.
Additional Manufacturer Narrative
Section a3b: unknown/ asked but not available.Section b3: date of event: unknown, not provided.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1: contact's email address and phone number: unknown/ asked but not available.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records related to the device including labeling and complaint trending will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: june 19, 2025 section h3: evaluated by manufacturer: yes device evaluation: visual inspection revealed the lens to be stuck to a piece of paper with an unknown adhesive.The lens was cleaned and inspected; no issues were identified.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.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.No nonconformity report, documentation or labeling changes, and further escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.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, puerto rico 00610
• MDR Report Key: 22038211
• Report Number: 3012236936-2025-000141
• Device Sequence Number: 12827132
• Product Code: HQL
• UDI-Device Identifier: 05050474763128
• UDI-Public: (01)05050474763128(17)250429
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2025
• Device Model Number: DXW150
• Device Catalogue Number: DXW150U275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White