MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported there was myopic surprise post implantation of the intraocular lens (iol).It was stated that patient was unable to see clearly at any range and their daily activities were significantly affected.Therefore, the lens was explanted/exchanged.No incision enlargement, no vitrectomy, no sutures were required.No patient post-op injury.No other information was provided.
Additional Manufacturer Narrative
Additional information: upon further review, a duplicate file was received, which was later voided.It noted that replacement lens was a zxt225u220 4402821810, patient in satisfactory condition.Patient dob: (b)(6) 1954, patient initials: (b)(6), gender: female, weight: 110 lbs, race: possibly asian, ethnicity: possibly asian.The different sections in the file that are affected have been updated accordingly.Section a2: date of birth: (b)(6) 1954.Section a3: gender: female.Section a: weight: 110 lbs.Section a: race/ethnicity: asian/not hispanic.As per the information received, there is a significant change of 1.5d between the original lens and replacement lens used.Additionally, original lens used (zkb00) was replaced with a different model lens (zxt225 toric lens), which indicates that there was astigmatism, which could not be treated with the originally implanted lens (zkb00).Hence, the adverse event occurred cannot be attributed to the original lens initially implanted and therefore, the event is being assessed as not reportable per amo-04-s005.Therefore, this correction mdr is submitted to reflect this new reportability decision.There will no longer be any further reporting under mfr report number 2648035-2021-08142.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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12257027
• Report Number: 2648035-2021-08142
• Device Sequence Number: 3635221
• Product Code: MFK
• UDI-Device Identifier: 05050474560154
• UDI-Public: (01)05050474560154(17)241024
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 10/24/2024
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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
• Patient Weight: 50