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

Model Number	PCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Phone: (b)(6) device evaluation: material was not returned.Therefore, the sample evaluation could not be performed, and the reported issue could not be verified.The complaint cannot be confirmed and either a product deficiency can be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional 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.
Event or Problem Description
It was reported that pcb00 lens during surgery did not have the second haptic when implanted into the patients' eye.Lens was implanted and removed after that.No further information available.
Additional Manufacturer Narrative
Device evaluation: the device was evaluated under microscope and scarce amount of viscoelastic was observed.The plunger and pushrod was observed in advanced position.No lens was observed in the device.No issues found.The reported issue haptic detached was not verified.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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
• MDR Report Key: 11571764
• Report Number: 2648035-2021-07398
• Device Sequence Number: 4205975
• Product Code: HQL
• UDI-Device Identifier: 05050474558151
• UDI-Public: (01)05050474558151(17)231209
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 12/09/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000145
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1