MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM; INTRAOCULAR LENS/ MONOFOCAL IOLS

Model Number	DIB00
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	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown; requested but not provided.Implant date: if implanted, give date: not applicable, as there was no indication that the lens was implanted.Implant date: if explanted, give date: not applicable, as there was no indication that the lens was implanted.Serial number: unknown, information was requested but not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Unique identifier (udi) number: unknown, as the serial number was not provided.Device evaluated by mfr: the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Device manufacture date: unknown, as the serial number was not provided.Multiple attempts have been made to obtain additional information regarding the event and to obtain suspect product for evaluation; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was very hard to turn and the lens looked defective.The surgeon had to use a back-up lens.No further information was provided.

• Brand Name: TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS/ MONOFOCAL IOLS
• 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: 16036873
• Report Number: 3012236936-2022-03178
• Device Sequence Number: 5643444
• Product Code: HQL
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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: DIB00
• Device Catalogue Number: UNK-DIB00
• Was Device Available for Evaluation?: No
• 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: 12/05/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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