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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: information unknown not provided.Date of event: unknown not provided.If implanted, give date: not applicable as the lens was not implanted, there was no patient contact.If explanted, give date: not applicable as the lens was not implanted, there was no patient contact.(b)(6).The intraocular lens (iol) is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that the intraocular lens (iol) was defective.The plunger stuck to the lens.It was reported that there was no patient contact.The material is not available for investigation.Through follow ups it was confirmed that there was an issue with the plunger rod and that the lens was damaged due to this issue.No additional info available.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on: 21 december 2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection revealed that there was an overridden lens in the lens module and that the plunger rod had been bent.The handpiece was disassembled and revealed no further issues.The lens was removed, and cleaned, and a cosmetic issue was identified.The complaint issue lens damaged could not be confirmed.The complaint issue plunger rod issue could be confirmed, but cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search was performed and there are no nonconformance related to this production order (po).During the record review for this production order, the miq (measurement iol quality) process was also reviewed.The lens was processed and inspected according to established procedures.No deviation was found during processes related to the complaint issue reported.The search revealed that no other complaints have been received for this production order.Conclusion: based on the limited information provided; it was not possible to determine an indication of a product malfunction or quality deficiency.There were no safety signals for similar reports from our post market surveillance activities.Subsequently, it is not required to initiate a nonconformity report, or escalation.Johnson and johnson surgical vision will continue to monitor the reported issue.All pertinent information available to johnson and 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: 12717044
• Report Number: 2020664-2021-07936
• Device Sequence Number: 15057948
• Product Code: HQL
• UDI-Device Identifier: 05050474558229
• UDI-Public: (01)05050474558229(17)231029
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/04/2022

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: 10/29/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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