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

Model Number	AR40E
Medical Device Problem Code	Material Fragmentation (1261)
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	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section e1: telephone number: (b)(6).Section h3-other (81): 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.An attempt has been made to obtain missing information; however, no definitive 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 an intraocular lens (iol) was implanted by the doctor in the patient's right eye; however, after inserting the iol into the eye, the doctor noticed that one of the haptics got stuck in the cartridge.The doctor explanted the iol immediately and implanted another lens of the same model.No other information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the information indicating there was an incision enlargement, there was no patient injury and no delay reported and that the patient outcome is unknown were inadvertently not entered in the initial mdr report; therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section b5: there was an incision enlargement, but no delay and no patient injury reported.The patient outcome is unknown.Section h6: health effect impact code: 4625 (hs-incision enlarged : intra operative complications).Section h6: health effect clinical code: 4581 (hs-incision enlarged : intra operative complications).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that health professional box in section g2 of initial report submitted was not marked.This supplemental report is submitted to correct this.Field below is updated: section g2 box: health professional.(checked).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: 17406391
• Report Number: 3012236936-2023-01940
• Device Sequence Number: 14927738
• Product Code: HQL
• UDI-Device Identifier: 05050474501935
• UDI-Public: (01)05050474501935(17)271204
• 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,Followup
• Report Date (Section B): 01/11/2024

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: AR40E00110
• 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: 09/25/2023; 01/10/2024
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/26/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2022
• 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: Female
• Patient Ethnicity: Hispanic