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

Model Number	Z9002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown, information not provided.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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon noticed the trailing haptic was not attached to the intraocular lens (iol) during insertion into the patient's operative eye.The lens was then cut out and removed without any incident.Another competitor lens was placed as the replacement.No further information was available.
Additional Manufacturer Narrative
Section a2: age/date of birth: 10/31/1947 section a3: gender: female.Section d9: device available for evaluation: yes section d9: returned to manufacturer on: sep 30, 2021 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptic and that the lens was received with a cut on the optic body, which is consistent with a lens handled during removal.The lens was cleaned, and a detached haptic, a damaged haptic (bent), and a torn iol were observed.The complaint issue was confirmed; however, based on the condition of the returned product no further testing can be performed.No product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed two additional investigation request (ir) for this production order number has been received, however, the complaints were not confirmed and no escalations were required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL 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: 12523899
• Report Number: 2020664-2021-07490
• Device Sequence Number: 17435400
• Product Code: HQL
• UDI-Device Identifier: 05050474530799
• UDI-Public: (01)05050474530799(17)251007
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 10/07/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• 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: Female