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

Model Number	AR40M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight and ethnicity: unknown/ not provided.If implanted, give date: not applicable, as the lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as the lens was removed/replaced during the same procedure.Telephone number: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation the lens cracked.Part of the lens and the trailing haptic was still in the injector close to the bevel.No sign of resistance/entrapment was seen during injection.The lens was fully inserted, and then removed and replaced during the same procedure.The patient fully recovered and daily activities were not significantly affected.Sutures were required and medication was prescribed.Medication and sutures were believed to be part of the normal standard of care.There were no other surgical interventions or delay reported.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no additional/ no similar complaint folder has been received for this production order number.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 and 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12663291
• Report Number: 2020664-2021-07779
• Device Sequence Number: 16451700
• Product Code: HQL
• UDI-Device Identifier: 05050474501799
• UDI-Public: (01)05050474501799(17)260128
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/06/2021

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 Expiration Date: 01/28/2026
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown