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

Catalog Number	GCB0000185
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
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 d6a: implant date: n/a - lens was not implanted.Section d6b: explant date: n/a - lens was not 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.
Event or Problem Description
It was reported that during handling and prior to insertion of the intraocular lens (iol), the iol was found to be in two pieces when screwing the lens forward.A new iol was opened for use.There was no patient contact with the device.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 11-mar-2026 section h3 - device evaluated by manufacturer? yes device evaluation: visual inspection of the complaint device revealed that the lens was stuck in the cartridge and torn.Ophthalmic viscosurgical device (ovd) was not observed to be distributed throughout the cartridge.The lens module was opened and inspected and no issues were identified.The lens was removed from the cartridge and cleaned and was observed to be torn in the haptic optic junction of the lens.Damage on the surface of the lens and haptics were also observed.The complaint issue "lens damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.The other observed issues could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 24473410
• Report Number: 3012236936-2026-000041
• Device Sequence Number: 10278102
• Product Code: HQL
• UDI-Device Identifier: 05050474620575
• UDI-Public: (01)05050474620575(17)281021
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GCB0000185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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
• Patient Sex: Unknown