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

Model Number	GCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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 - if implanted, give date: n/a - lens was not implanted.Section d6b - if explanted, give date: n/a - lens was not implanted.Section e1 - telephone number: (b)(6).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and no product quality deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction were found.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was an issue with one of the haptics of the preloaded monofocal intraocular lens (iol).The issue was observed during handling and prior to insertion.There was no patient contact with the device.Through follow up, we learned from the surgeon that it felt as if the leading haptic was stiff.He tried to load it the old way, but still had the same issue.No further information was provided.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 02-apr-2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification was performed on the suspect product.The cartridge was received with viscoelastic residue observed to be distributed evenly throughout the cartridge; no cartridge or cartridge tip issues were identified that could cause or contribute to the complaint issue reported.The lens was observed to be coated in viscoelastic residue.The lens was cleaned revealing scratches on the lens.No further evaluation was performed.The complaint issue "haptic damaged" was not identified during product evaluation.The other observed issues could not be confirmed to be related to the manufacturing or design process.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: 21733936
• Report Number: 3012236936-2025-000065
• Device Sequence Number: 12945361
• Product Code: HQL
• UDI-Device Identifier: 05050474620520
• UDI-Public: (01)05050474620520(17)270712
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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 Model Number: GCB00
• Device Catalogue Number: GCB0000160
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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
• Patient Sex: Unknown