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

Model Number	GCB00
Medical Device Problem Codes	Material Fragmentation (1261); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implantation of an intraocular lens (iol) a fragment was released immediately after implantation and was located at the bottom next to the haptic.A small chip was noted to be missing from the edge of the optic at the 2 o¿clock position, and the released fragment was described as noticeably larger than the missing chip.The event was identified after implantation, and there were no reported patient injuries.The patient¿s status was reported as fully recovered.There was no surgical intervention outside of the standard care.The fragment was removed from the eye during the procedure, and the iol was fully implanted as intended.No further information available.
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: unknown, not provided.Section d6a - if implanted; give date: unknown/not provided.Section d6b - explant date: not applicable - lens remains implanted; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h3: the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, for this device will be performed.Upon completion of the 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: 24918563
• Report Number: 3012236936-2026-000082
• Device Sequence Number: 21447698
• Product Code: HQL
• UDI-Device Identifier: 05050474620599
• UDI-Public: (01)05050474620599(17)281124
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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 Model Number: GCB00
• Device Catalogue Number: GCB0000195
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2025
• 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