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 Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a5: ethnicity: unknown/ not provided.Asku.Section d6a: if implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section d6b: if explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section h3-other (81): the device was not returned for evaluation as it was discarded; 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 additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was fully implanted in a patient¿s right eye and removed in the same procedure due to broken haptic.A replacement lens of the same model but lower diopter (3.5 d) was successfully implanted.It was indicated that sutures were required.The patient is well.The product is not available for return as it was discarded.No further information was provided.The same issue reported with two ar40e lenses.This report is for the lens with sn (b)(6).A separate report will be submitted for the other lens.
Additional Manufacturer Narrative
Additional information received from the doctor confirmed that the same issue, broken haptic noticed on both lenses with the same eye of the patient during the same procedure.That the issue was noticed after the lens was fully inserted.The doctor was not sure which lens was inserted first and which one second.It was indicated that one suture was used prophylactically.The lens was inspected before loading and the haptics were fine.Per the doctor, it is possible that the problem was due to loading issues.Incision enlargement was required with the first lens.There were no patient complications or injury.No further information was provided.The following fields were updated according to the new information received: section h6: health effect - impact code: 4625 - additional surgery (incision enlargement & sutures).Section h6- health effect - clinical code 4581 - no code available (incision enlarged).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information/corrected data: in review, it was noted that the following additional information inadvertently was not included in the follow up mdr report #1; therefore, the information has been captured in this supplemental mdr report accordingly: section b5: additional information received from the account clarified that the lens serial number 2059542225 inserted first, serial number 2015272147 added second.This mdr report pertains to the first lens.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: 18415970
• Report Number: 3012236936-2023-03314
• Device Sequence Number: 8174359
• Product Code: HQL
• UDI-Device Identifier: 05050474501867
• UDI-Public: (01)05050474501867(17)270620
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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 Model Number: AR40E
• Device Catalogue Number: AR40E00040
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 01/19/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/19/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD CARTRIDGE, LOT CM11471.
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White