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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer has had issues opening the preloaded monofocal intraocular lens (iol), in particular not folding correctly during procedure.Patient status is unknown.Through follow up we learned that the surgeon had difficulty advancing the lens and once advanced, the lens looked odd.Further follow up revealed that there was no patient involvement with the device and no material was available for return as the device has already been discarded.No further details were provided.
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, as the lens was not implanted.Section d6b - explant date: not applicable, as the lens was not implanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation as it has been discarded.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.

• Brand Name: TECNIS SIMPLICITY
• 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: 18521301
• Report Number: 3012236936-2024-00102
• Device Sequence Number: 6545444
• Product Code: HQL
• UDI-Device Identifier: 05050474636019
• UDI-Public: (01)05050474636019(17)260521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 05/21/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000165
• 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: 01/03/2024
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2023
• 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