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

Model Number	AR40E
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: information unknown/ not provided per country's personal data privacy legislation/policy.Section d6a: if implanted, give date: not applicable, as lens was removed during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed during the same procedure.Section e1: initial reporter telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was a white deposit on the intraocular lens (iol) and it was introduced into the patient's eye as lens was being implanted.The iol was removed from the patient's eye.There was no delay in treatment or other interventions reported.No further information was provided.
Additional Manufacturer Narrative
Additional information section d9: device available for evaluation: yes.Date returned to manufacturer: aug 3, 2023.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received covered in viscoelastic residue and therefore alleged inclusions could not be observed.The lens was inadvertently cleaned and scratches which could be attributed to cleaning were observed.Due to the lens being inadvertently cleaned no further evaluation could be performed for the complaint issue with the returned product.The customer provided photo attached in the complaint folder was reviewed and an opaque substance is observed in the eye in the location of the lens.The nature of the substance cannot be confirmed from a photo assessment and therefore no further evaluation could be performed.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 17446987
• Report Number: 3012236936-2023-01993
• Device Sequence Number: 7383351
• Product Code: HQL
• UDI-Device Identifier: 05050474502161
• UDI-Public: (01)05050474502161(17)260217
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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 Expiration Date: 02/17/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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: Unknown