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

Model Number	AR40M
Medical Device Problem Codes	Defective Component (2292); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4 and a5: unknown; requested but not provided.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section e1: telephone number: (b)(4).Section h3-other (81): the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of photos and video, 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.Section h6: health effect - clinical code: code 4581 is to capture device decentered or dislocated or tilted subluxated or wrong position.Attempts were 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 the intraocular lens (iol) came with different haptics; one haptic was longer than the other, and when it entered the left eye, the iol became decentered and tilted.There was no patient injury.No medical or surgical intervention has been performed at this time.At the patient's first postoperative visit on (b)(6) 2023, the patient was experiencing double vision and the iol was displaced.The next appointment was scheduled for seven days later to confirm the outcome.The surgeon will explant the lens and implant another one, but no date is scheduled yet for the planned explant.The iol remains implanted at this time.No further information was provided.

• 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: 17167415
• Report Number: 3012236936-2023-01552
• Device Sequence Number: 5818622
• Product Code: HQL
• UDI-Device Identifier: 05050474501799
• UDI-Public: (01)05050474501799(17)270829
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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: AR40M
• Device Catalogue Number: AR40MN0030
• 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: 05/26/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Race: White