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	Endophthalmitis (1835)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the site has identified a bacterial infection affecting their ophthalmology patients.At this time, it is not known whether the infection is related to johnson and johnson lenses, but the hospital has notified all ophthalmology suppliers as a precaution.Through follow up, we learned that a total of five patients were affected by suspected endophthalmitis, specific dates below.All five patients were treated with intravitreal antibiotics, oral and topical antibiotics, and one patient also required topical steroids.As we cannot rule out any products, all suspect products are reported with all interventions provided.At present there are no long-term effects on the patient's vision and no further interventions have been required.Through further follow up, we learned that the suspect products for these complaints are gcb model intraocular lens (iol), laminar flow phaco tips, tubing sets, and dk9000 as they were used on each patient.As the dk9000 is a device the clinic sterilizes themselves, this is listed as a concomitant device and not being reported against.There was no differentiation as to which patient had which specific device and as such, all files will remain coded with topical steroids.(b)(6) 2026: intravitreal antibiotics, oral and topical antibiotics only.(b)(6) 2026: intravitreal antibiotics, oral and topical antibiotics only.(b)(6) 2026: intravitreal antibiotics, oral and topical antibiotics only.(b)(6) 2026: intravitreal antibiotics, steroids and topical antibiotics only.(b)(6) 2026: intravitreal antibiotics, oral and topical antibiotics only.No further information has been provided.This report is for patient implanted with iol serial (b)(6).Separate reports will be submitted for the other patients involved.
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 b3 - date of event: date unknown, as information was requested but not provided.Section d6a - implant date: unknown, as information was requested but not provided.Section d6b - explant date: unknown, as information was requested but not provided.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 this review, if there is any further relevant information 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 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: 25451968
• Report Number: 3012236936-2026-000159
• Device Sequence Number: 16039127
• Product Code: HQL
• UDI-Device Identifier: 05050474620629
• UDI-Public: (01)05050474620629(17)280901
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 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: 05/15/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPO73 PACK, ELLIPS FX PHACO AND DK9000 HANDPIECES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown