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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown; requested but not provided.Date of event: unknown; requested but not provided.If implanted, give date: not applicable, as there was no indication that the lens was implanted.If explanted, give date: not applicable, as there was no indication that the lens was implanted.Initial reporter telephone number: (b)(6).The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a non preloaded intraocular lens iol had optical damage.It is unknown if there was patient contact.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up, it was reported that at the time of the implant the surgeon verified that the lens handle was broken.There was no use error, it was a factory defect.The lens/cartridge touched the eye.During insertion a defect in the lens was noted and the lens was not inserted into the left eye.It was decided to change the lens and insert a new one.The issue was noted during handling, prior to insertion.The procedure was completed successfully using a back-up lens (same model and diopter).There was no patient injury.No medical or surgical interventions were required.The lens has been discarded.Additionally, information received on patient¿s gender is male; event date was feb.9, 2023.Doctor¿s full name: (b)(6), with email address of (b)(6).Fields below updated: section a3: gender: male.Section b3: event date: feb.9, 2023.Section e1: complaint reporter first name and last name: (b)(6).Section e1: email address: (b)(6).Section h6: type of investigation: 4115: device discarded.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• 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: 16686737
• Report Number: 3012236936-2023-00829
• Device Sequence Number: 7454810
• Product Code: HQL
• UDI-Device Identifier: 05050474502093
• UDI-Public: (01)05050474502093(17)271117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/03/2023

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 Model Number: AR40E
• Device Catalogue Number: AR40E00195
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: Male