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	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.Telephone number: (b)(6).The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there are two techno vigilance notifications.In both cases, the supplier collects the materials and sends them to the manufacturer for analysis, after the analysis we receive the feedback.If it is found that there really was a manufacturing defect, the supplier sends a return note referring to the supplies, generating a credit for the hospital, "lens with a crack".No other information was provided.This report captures event for suspect product ar40e, serial number (b)(4).The other suspect product mentioned will be captured in a separate report.
Additional Manufacturer Narrative
Additional information: section a2, age - 83, section a2, date of birth - (b)(6) 1939, section a3, gender - male, customer also reported that the intraocular lens (iol) was fully inserted.It required a removal and replacement due to the lens being damaged.There was a delay in treatment.The incision was enlarged.Sutures were required and medication was prescribed.Patient's initials: (b)(6), affected eye: left eye, all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
On 27-feb-2023, the following additional information was received: section a5: ethnicity, patient is latino but not hispanic.Section a5: race, white.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on dec 04, 2023.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection reveal that the complaint lens was observed to be coated in viscoelastic residue.The lens was cleaned, and damage on the surface and edges of the lens were observed.The lens was torn in the haptic region of the lens separating the haptic from the lens; the other haptic was damaged.The complaint issue "lens damaged" was identified during 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.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.

• 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: 15955132
• Report Number: 3012236936-2022-03067
• Device Sequence Number: 15279670
• Product Code: HQL
• UDI-Device Identifier: 05050474502086
• UDI-Public: (01)05050474502086(17)270304
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00190
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/27/2023; 02/20/2024
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/16/2023; 03/21/2023; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White