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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown, not provided.If implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.If explanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a sensar intraocular lens (iol) was inserted into the patient's left eye but was removed during the same procedure due to break in the capsular bag.A vitrectomy was performed and the iol was replaced with a non-johnson & johnson lens.The patient is reportedly stable post-surgery.No additional information provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: jun 10, 2021 section h3: evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during removal and replacement.Haptic damage (bent) was also observed but can be attributed to handling and cannot be confirmed to be related to manufacturing.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that 1 complaint was received for this production order.However, it is not related to this reported issue.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
• MDR Report Key: 11861341
• Report Number: 2648035-2021-07760
• Device Sequence Number: 3789380
• Product Code: HQL
• UDI-Device Identifier: 05050474548701
• UDI-Public: (01)05050474548701(17)250131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLATINUM CARTRIDGE LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention