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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or dob, weight, ethnicity: unknown, information not provided.Phone number: (b)(6).If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The device has not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation 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
It was reported that an intraocular lens (iol) was damaged.Through follow-up it was clarified that after the lens was inserted in the eye it was noted that one haptic was missing.The lens was removed from the eye and replaced with another lens of the same diopter.No further information provided.
Additional Manufacturer Narrative
Corrected data: as part of an internal review of our mdrs it was identified that the following fields need to be corrected: section h6: health effect - impact code: 2199 (no health consequences or impact) provided on the initial report needs to be corrected.The correct code is 4631 (more complex surgery) as the lens was removed and replaced in the initial surgery.This report is being submitted to replace code 2199 with code 4631.Section h6: medical device problem code: 1069 (break) provided on the initial report needs to be corrected.The correct code is 1261 (material fragmentation) to capture the haptic detached issue.This report is being submitted to replace code 1069 with code 1261.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Note: acknowledgement 2 for this report was received on 09/23/2022.There was a delay in receiving acknowledgement 3 due to a cdrh system issue.Multiple follow-ups were conducted with the esg help desk.On 10/18/2022 esg responded requesting to resubmit the mdr.Therefore, this report is being resubmitted on 10/19/2022.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12685769
• Report Number: 2020664-2021-07866
• Device Sequence Number: 4012259
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)231207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 12/07/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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
• Patient Sex: Unknown