MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM; POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: implant date does not apply because the lens was removed during the same procedure.If explanted; give date: explant date does not apply because the lens was removed during the same procedure and has never been implanted.Telephone number: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It has been reported issues with a pcb00.Defective lens because embolus went over the lens.The lens was partially inserted and the issue was at first noticed during implantation/application.No patient injury has been reported, patient is fully recovered.Lens removed and replaced during the same procedure.The material is available for investigation if required.Patient information cannot be provided due to personal data privacy legislation/policy.No further information has been provided.Note: embolo in spanish is plunger in english.So by embolo over lens means override.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes.Date returned to manufacturer: 4/28/2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection was performed on the intraocular lens (iol) returned.The plunger and pushrod was observed in advanced position.The pushrod was observed that overrides the lens in the cartridge.Residues of viscoelastic material was observed on cartridge.The cartridge tip was observed slightly deformed.The lens was observed stuck in cartridge and the leading haptic was observed not folded and detached.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepare for surgical process.The complaint issue reported was verified manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.There are no discrepancies found during the mrr (manufacturing record review) related to this complaint.The units were released according specification in compliance with the product intended use as required.A search of complaints related this production order (po) was performed.The search revealed no additional complaint folder for this po number: conclusion: based on the manufacturing record review, analyzed of the returned and historical review there is no indication of a product malfunction or quality deficiency.No nonconformity report, escalation, documentation is required all pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
• Common Device Name: POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11828571
• Report Number: 2648035-2021-07791
• Device Sequence Number: 2989876
• Product Code: HQL
• UDI-Device Identifier: 05050474558397
• UDI-Public: (01)05050474558397(17)231102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 11/02/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1