MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
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 by the customer that ppg st mary¿s portsmouth has identified a bacterial infection affecting their ophthalmology patients.At this time, it is not known whether the infection is related to the company¿s 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 the suspect products for these complaints are gcb intraocular lens (iol), laminar flow phaco tips, pacho handpiece, tubing sets and dk9000 were used on each patient.There was no differentiation as to which patient had which specific device and as such, all files will remain coded with topical steroids.As we cannot identify the phaco handpiece used in conjunction with this specific iol, they are being reported as unknown serial numbers.All possibilities are as below.(b)(6).(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.
Additional Manufacturer Narrative
Section a2, 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 d4 - serial#: unknown/ not provided section d6a - implant date: not applicable to suspect device section d6b - explant date: not applicable to suspect device.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: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25453258
• Report Number: 3012236936-2026-000157
• Device Sequence Number: 8708663
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981116
• 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: 690880
• Device Catalogue Number: 690880
• 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: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown