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

Model Number	DFW375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between jul 28, 2021 and sep 1, 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the left eye of a patient in a secondary surgical procedure due to patient¿s complaint of blurry vision.The patient was uncomfortable and wanted the lens out as soon as possible.Uncorrected distance visual acuity (ucdva): 20/40 ( isolated letters only), uncorrected binocular visual acuity (ucnva)- j8 @16-18inxhes uncorrected intermediate visual acuity (uciva)- 20/60, medial rectus (m.R.): +.75-.75 @115, pinhole- no improvement macular optical coherence tomography (oct)- clear.No vitrectomy, no incision enlargement and /or no sutures were required.A replacement lens of different model and diopter (22.0) diopter was used.The patient is doing fine.No further information was provided.
Additional Manufacturer Narrative
The following sections have been updated accordingly: section a2, dob: dec 2, 1954.Section a4, patient weight: 250 pounds.Section a5, ethnicity and race: non-hispanic, white.Section b3, date of event: (b)(6) 2021.Section d9: device available for evaluation ¿ yes, returned to manufacturer on 10/05/2021.Section h3: device evaluated by manufacturer ¿ yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and no cosmetic issues were identified.The complaint issue could not be confirmed, and 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.Based on additional information received information the proceeding codes were added in h6: health effect: clinical code: foreign body sensation in eye= 1869.Visual disturbances = 2140.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12531190
• Report Number: 2020664-2021-07514
• Device Sequence Number: 13786898
• Product Code: MFK
• UDI-Device Identifier: 05050474753068
• UDI-Public: (01)05050474753068(17)240319
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 03/19/2024
• Device Model Number: DFW375
• Device Catalogue Number: DFW375U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White