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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown/not provided.If implanted; give date: n/a, lens was not implanted.If explanted; give date: n/a, lens was not implanted; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis preloaded intraocular lens (iol) malfunctioned, and that one haptic was broken/bend.There was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
Additional information: upon further review, information was received that event date was jun 7, 2021 and that patient is male.The following section have been updated.Section a3: gender: male section b2: event date: 06/17/2021.Section d9.Device available for evaluation? yes.Returned to manufacturer on: 10/04/2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed a pre-loaded inserter with viscoelastic residue on the inside of the cartridge.Further inspection revealed that the lens was stuck in the cartridge and that the plunger had overridden the lens.The inserter was disassembled and no assembly issues were identified.The lens was removed from the cartridge and cleaned, a detached haptic as well as lens damaged were observed.Based on the return condition of the lens no further product evaluation could be performed on the lens.Furthermore, via the definition of haptic damaged in amo-04-d024 rev.7 the complaint issue could not be confirmed and could not be confirmed to be related to a manufacturing issue, suggested by the handpiece presenting with proper assembly.Therefore, no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that there was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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: 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: 12483102
• Report Number: 2020664-2021-07436
• Device Sequence Number: 3848271
• Product Code: HQL
• UDI-Device Identifier: 05050474558014
• UDI-Public: (01)05050474558014(17)220316
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: 03/16/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 09/07/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2019
• 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: Male