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

Model Number	GAB00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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 d6b - explant date: not applicable - lens remains implanted.Section e1 - telephone number: (b)(6) device evaluation: no suspect product was received; however, a photograph provided by the customer were evaluated.The picture showed an eye being implanted with a sensar one piece intraocular lens preloaded in the smartload delivery system model gab00.A blakish/grayish filament measuring approximately 1.5 mm and located between the lens mid periphery and periphery at 11:00 in relation to the picture orientation can be observed.It could not be determined if the particle is embedded in the lens material or if it just on the lens surface.Based on the particle¿s location and an optical review of the supplied images, it is not expected to produce a visual or optical effect for the patient while the lens remains implanted.However, a definitive assessment of optical impact cannot be made from a photograph alone.Likewise, the particle¿s composition, its root cause, and its exact position within the lens cannot be determined from the provided image; therefore, any conclusive judgment about clinical implications related to these characteristics is not possible from image evaluation alone.The complaint issue "inclusions" was not identified during product evaluation.The other observed issues could not be confirmed to be related to the manufacturing or design process.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, the product was released within specification.No product deficiency or product malfunction could be identified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implantation of the intraocular lens (iol) in the patient's left eye, the surgeon observed a thread within the lens material at the 11 o¿clock position, which was not identified as a cortex thread or a scratch, but a thread that is inside the material.The lens remains implanted.Through follow ups, we learned that the iol was implanted through a completely normal phacoemulsification procedure.No lens exchange is planned.Account indicated that the iol implantation of the other eye (right) took place on (b)(6) 2025, during which visual acuity of the left eye was measured as 0.8 with no complaints from the patient.No further details were provided.

• 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: 23874265
• Report Number: 3012236936-2025-000331
• Device Sequence Number: 5571088
• Product Code: HQL
• UDI-Device Identifier: 05050474621855
• UDI-Public: (01)05050474621855(17)280916
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: GAB00
• Device Catalogue Number: GAB0000235
• 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: 11/27/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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