MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU225
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - unknown, but the best estimate is (b)(6) 2020.If implanted; give date: n/a (not applicable).Unknown, not provided.If explanted; give date: n/a (not applicable).Lens remains implanted.Phone numbers: (b)(6).The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, failure analysis of the complaint device cannot be completed.A review of the device history 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
The customer reported that a patient complained of glare symptoms at his one-month post-operative visit after the implantation of a toric intraocular lens (iol).The surgeon dilated the patient's eye and saw a rectangular foreign body between the iol and posterior capsule.The surgeon has seen small cortical/capsular fragments trapped in the capsule post-operatively which disappeared with yag capsulotomy, so he proceeded with the laser, but the foreign body is extremely firmly adherent, and doesn't move at all with the laser.It almost looks like a piece of plastic or cellophane stuck onto the posterior surface of the iol.The lens remains implanted and no patient injury reported.No further information provided.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11383196
• Report Number: 9614546-2021-07050
• Device Sequence Number: 17005078
• Product Code: HQL
• UDI-Device Identifier: 05050474659056
• UDI-Public: (01)05050474659056(17)240830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 08/30/2024
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention