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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of a monofocal intraocular lens (iol) was seen to be bent once inserted into a patient's right eye.It was indicated that the issue was not due to use error.The lens was removed and the surgery completed with a backup lens during the same procedure.A replacement lens of the same model and diopter was used.There was no unplanned vitrectomy required and no medication outside the standard of care required.It is unknown if there was any delay in procedure.The patient outcome is unknown.Additional information from the doctor indicated that there was a dislocation of the crystaline lens, so the lens and capsule were removed in total and the iol was placed via a scleral fixated technique without suturing the lens.The sclerotomy sites were sutured.This is standard for this procedure.The cornea also had a cornel suture placed which is also standard.The patients vision is now 20/70 back to his baseline and best expected corrected visual acuity.No further information was provided.
Additional Manufacturer Narrative
Additional information/corrected data: additional information indicated that the patient's weight was 63kg (138lbs).In review, it was noticed that an incorrect value (16kg) was inadvertently entered in the section "a4 -weight"; therefore the information has been corrected on this supplemental mdr report and the following field has been corrected accordingly: section a4: weight: 63kg (138lbs).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the returned suspect product and found the lens was received cut and both haptics were detached.One haptic remained in the drill hole, but was cut.The optic body was also damaged.No further evaluation was performed.The complaint issue "haptic damaged" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint was received for this po.However, based on the results, no escalations are required.Conclusion: based on the investigation, no malfunction or product deficiency was 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: 20011705
• Report Number: 3012236936-2024-000228
• Device Sequence Number: 7201673
• Product Code: HQL
• UDI-Device Identifier: 05050474501973
• UDI-Public: (01)05050474501973(17)290318
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2024

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: AR40E00135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 08/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/22/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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 UNKNOWN.
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American