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

Model Number	AR40M
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted.No further information was provided.
Additional Manufacturer Narrative
Weight, ethnicity: unknown; requested but not provided.Date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2022 and (b)(6) 2023.If explanted, give date: unknown, information was requested but not provided.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.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.
Additional Manufacturer Narrative
Additional information: additional information was received reporting that the explant was performed on (b)(6) 2022 in the left eye.There was no issue or malfunction with the lens.The issue was first noted on (b)(6) 2022.After following up with the surgeons and nursing staff, it is recalled that the lens was possibly loaded incorrectly and was then explanted.Another johnson and johnson intraocular lens (iol) was implanted as replacement (same model, same diopter).There was no patient injury.There was no medical or surgical intervention required.There was no incident.The patient had no complications.The device was discarded.Additional information provided: patient gender is female, date of birth is on (b)(6) 1959, race arabic, weight 165 pounds.No further information was provided.The following sections have been updated accordingly: section a2: date of birth: on (b)(6) 1959.Section a3: gender: female.Section a4: weight: 165 pounds.Section a5: race: arabic.Section b3: date of event: sep 28, 2022.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.Correction: based on the additional information received, the codes from the initial mdr of 4629 - device revision or replacement, 1845 - eye injury, 2993 - adverse event without identified device or use problem and are no longer applicable.The following codes have been added to reflect the new information: section h6: health effect - impact code: code 4631 - more complex surgery.Section h6: health effect - clinical code: code 4582 - no clinical signs, symptoms or conditions.Section h6: medical device problem code: code 1670 - use of device problem.Based on the additional information received that the lens was removed and replaced in the same procedure due to the lens being possibly loaded incorrectly, and no quality issue with johnson & johnson iol; therefore, this event is assessed as not reportable.There will no longer be any further reporting under mfr report number: 3012236936-2023-00239.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: 16309901
• Report Number: 3012236936-2023-00239
• Device Sequence Number: 12283462
• Product Code: HQL
• UDI-Device Identifier: 05050474501720
• UDI-Public: (01)05050474501720(17)270818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0100
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG