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

Model Number	GAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) slipped into the back of the eye during implantation.Pars plana vitrectomy (ppv) was performed for retrieval of the iol.No further details were provided.
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: not applicable, lens was not implanted.Section d6b - explant date: not applicable, lens was not implanted.Section h6 -health effect - clinical code: 4581: no code available (device dislocation).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.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes section d9: returned to manufacturer on: 28-jul-2025 section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection under magnification was performed on the suspect product.The lens was found stuck in the mouth of the cartridge; the lead haptic was unfolded as the lens was not advanced far enough into the cartridge for the folding process to begin.Viscoelastic residue was not observed to be evenly distributed throughout the cartridge; no cartridge tip or cartridge issues were observed.The lens module was inspected revealing no issues; viscoelastic residue was observed on the lens module lid.The lens was removed from the cartridge and cleaned, revealing no issues.No further evaluation was performed.The complaint issues reported were not identified.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.The reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the product investigation has been reopened to address discrepancies between sections (device evaluation and the investigation report summary) device evaluation: visual inspection under magnification was performed on the suspect product.The lens was found stuck in the mouth of the cartridge.Based on the complaint description, it is indicated that the lens was placed in the cartridge after removal to be returned for evaluation.Viscoelastic residue was not observed to be evenly distributed throughout the cartridge; no cartridge tip or cartridge issues were observed.The lens module was inspected revealing no issues; viscoelastic residue was observed on the lens module lid.The lens was removed from the cartridge and cleaned, revealing no issues.The complaint issues reported were not identified during product evaluation.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.The reported issue could not be verified.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: 22302984
• Report Number: 3012236936-2025-000159
• Device Sequence Number: 8017074
• Product Code: HQL
• UDI-Device Identifier: 05050474621770
• UDI-Public: (01)05050474621770(17)270807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2025

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: GAB00
• Device Catalogue Number: GAB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 08/20/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/20/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown