MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; SENSAR 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	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information cannot be provided due to personal data privacy legislation/policy catalog number: partial catalog number indicated since the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.Implant/explant date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter telephone number: (b)(6).Device manufacture date: unknown as the serial number of the device was not provided.Device evaluation: product testing could not be performed because the product was not returned for evaluation.The complaint cannot be confirmed.Manufacturing record review: the manufacturing record and complaint history were not reviewed since the serial number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when implanting the intraocular lens (iol), it was noted that the haptic was broken.The lens was replaced.
Additional Manufacturer Narrative
Additional information and corrected data: section h3: device evaluated by manufacturer: yes.New information received indicated that the suspect product serial number (sn) is (b)(6).Therefore, this supplemental filing is to update the following fields per new information received: section d1: brand name: sensar iol.Section d2: common device name: intraocular lens.Section d2: device product code: hql.Section d4: serial number: (b)(6).Section d4: catalog #: ar40e00230.Section d4: unique identifier (udi) number: (b)(4).Section d4: expiration date: jul 02, 2026.Section h4: device manufacture date: jul 02, 2021.Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Date returned to manufacturer: 19 april 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received crushed inside the lens insert.Lens damage, scratches, and a detached haptic (not returned) were observed.No further issues or evaluation was performed.The complaint issue haptic damaged was not identified during photo and product evaluation.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• Common Device Name: SENSAR 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: 15795009
• Report Number: 3012236936-2022-02824
• Device Sequence Number: 5660302
• Product Code: HQL
• UDI-Device Identifier: 05050474502161
• UDI-Public: (01)05050474502161(17)260702
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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: 07/02/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 02/22/2023; 05/05/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/07/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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 Age: 73 YR
• Patient Sex: Male