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	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, 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, as information was requested but not provided.Section d4 - catalog number: a complete number is unknown, as product serial number was not provided.Section d4 - serial number: unknown/not provided.Section d4 - expiration date: unknown, as product serial number was not provided.Section d4 - udi number: unknown, as product serial number was not provided.Section d6a - implant date: not applicable, as there is no indication that the lens was implanted.Section d6b - explant date: not applicable, as there is no indication that the lens was implanted.Section e1 - telephone number:(b)(6).Section h3 - other (81): 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.Section h4 - device manufacture date: unknown as product serial number was not provided.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after inserting the cartridge into the shooter and while advancing the intraocular lens (iol), the plastic on the cartridge tip tore.No further information was provided.
Additional Manufacturer Narrative
Additional information: upon further review, it was noted that the following information was inadvertently not included in the initial mdr (mfr report number 3012236936-2023-01987).The section below have been updated in this filing: section b3 - date of event: 17-jul-2023.Section d4 - catalog number: gab0000285.Section d4 - serial number: (b)(4).Section d4 - expiration date: 24-mar-2026.Section d4 - udi number: (b)(4).Section h4 - device manufacture date: 24-mar-2023.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: 17504206
• Report Number: 3012236936-2023-01987
• Device Sequence Number: 16742792
• Product Code: HQL
• UDI-Device Identifier: 05050474621954
• UDI-Public: (01)05050474621954(17)260324
• 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): 10/04/2023

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: 03/24/2026
• Device Model Number: GAB00
• Device Catalogue Number: GAB0000285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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