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	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that haptic was broken into the patient eye.No further information is available.
Additional Manufacturer Narrative
Section d9: device available for evaluation ¿ yes, returned to manufacturer on 09/29/2021 section h3: device evaluated by manufacturer ¿ yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was loaded into the cartridge.One haptic was observed to be both damaged (bent) and have a portion detached.The lens was cleaned, and lens damage on the edge of the optic body was observed.The complaint issue was confirmed; however, based on the fact that the lens was handled during loading this may be attributed to handling and cannot be confirmed to be related to manufacturing.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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
• MDR Report Key: 12492676
• Report Number: 2020664-2021-07207
• Device Sequence Number: 4082018
• Product Code: HQL
• UDI-Device Identifier: 05050474501850
• UDI-Public: (01)05050474501850(17)260508
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 05/08/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR