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

Model Number	GCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Infections (4466)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon performed eight cataract surgeries on the same day before easter.At the weekly check-up everything looked fine, but at the monthly check-up there was a cloudy light path in 3 eyes.When treated with spersadex it disappeared quickly.The surgeon does not suspect our products and has changed everything that can be changed.Through follow ups it was confirmed that the 3 eyes were from 3 different patients.Through further follow up, we learned that 7 patients are involved and there are 3 different event dates.It was confirmed that the customer is reporting infection in all 7 patients.However, on june 13th it was learned that the surgeon does not believe this incident is related to the implanted johnson and johnson intraocular lenses (iols).Through follow up on june 16th we learned it was a mild infection, all patients responded fast to tobradex except one that took a little more time.There is no material available for investigation as all iols remain implanted.No further information was provided.Note: 6 additional reports will be filed for the other 6 patients.This is report 5 of 7.
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b - explant date: not applicable, as lens remains implanted.Section e1 - telephone number: (b)(6).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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• 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 ; 7142478552
• MDR Report Key: 22342828
• Report Number: 3012236936-2025-000169
• Device Sequence Number: 15583350
• Product Code: HQL
• UDI-Device Identifier: 05050474620629
• UDI-Public: (01)05050474620629(17)270809
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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 Model Number: GCB00
• Device Catalogue Number: GCB0000210
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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: Unknown