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

Model Number	GAB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.The lens was not implanted.Section d6b - explant date: not applicable.The lens was not implanted.Section e1: email address: unknown/not provided, as information was asked but it was not provided.Section e1 - telephone number (b)(6) section h3 - other (81): the product 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was properly placed in the shooter and handled normally; however, when attempting to implant, the plastic at the tip of the cartridge slightly crumbled, making further use and implantation impossible.It is not clear if it was the handling of the cartridge or perhaps the shooter that caused the problem.A new lens from the stock was implanted without any issues.No further details were provided.This is report 2 of 2.A separate report is being submitted for the other gab00 unit with the same issue.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date received by manufacturer: 29-nov-2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the complaint device was returned for evaluation.Visual inspection of the suspect handpiece found no issues with the device.The investigation site indicated that the module broke during handling and evaluation.The cartridge presented with a crack to the cartridge tip.Viscoelastic residue was observed to be distributed thought the length of the cartridge indicating an adequate amount was used.No further issues were identified.The complaint issue "cartridge tip cracked/damaged" 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.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: 18052397
• Report Number: 3012236936-2023-02694
• Device Sequence Number: 5954727
• Product Code: HQL
• UDI-Device Identifier: 05050474621817
• UDI-Public: (01)05050474621817(17)260523
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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 Expiration Date: 05/23/2026
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000215
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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