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

Model Number	GAB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a plastic residue came out of the shooter while inserting the preloaded intraocular lens (iol).The surgeon had to use a phaco spatula to remove the individual plastic residues from the anterior chamber and from the iol.All residues were removed.The lens remains implanted.The patient has fully recovered.No further details were provided.
Additional Manufacturer Narrative
Section a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).Section h3 : the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, 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.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 04-mar-2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens was returned for evaluation.Visual inspection under magnification was performed on the suspect product.Two smartloads were received loose in a bag.Two serial numbers were given in the bag with this return and it could not be determined which smartload belonged to this complaint; therefore, the evaluation of both will be contained in this product investigation.Material could be observed to be extending from the tips of both devices.As it could not be determined which device belongs to which complaint, both devices were forwarded to an external laboratory for further evaluation.Per further analysis, the material is a mixture of polypropylene and sodium hyaluronate (naha).The fourier transform infrared (ftir) spectrum raw data output file was compared against the manufacturing process ftir library and did not yield any results with at least a 0.90000 correlation.The complaint issue "foreign material - loose" 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.No escalation was required.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: 21540171
• Report Number: 3012236936-2025-000051
• Device Sequence Number: 12512544
• Product Code: HQL
• UDI-Device Identifier: 05050474621909
• UDI-Public: (01)05050474621909(17)270515
• 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
• Report Date (Section B): 05/09/2025

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: GAB0000260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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