MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU225
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2020 and (b)(6) 2021.Manufacturer telephone number: (b)(4).Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified and no product deficiency could be identified.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 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.
Event or Problem Description
It was reported that a tecnis toric intraocular lens (iol) implanted into the patient's right (od) eye.The lens was oriented at 110°.The predicted refraction was a -.50+.07 at 21°.The surgeon ran the calculation twice.Her refraction today is +1.00+2.00x 010.The surgeon repeated her iol master and topography today and once again she is showing 1.95d cylinder @100 (her prev iolm showed 1.84d@106).Her corneal topography is consistent with the readings that are getting on her iol master.Through follow-up, it was learned that the lens has explanted from the patient's eye.The surgeon would like to know if iol was mislabeled or if it was a mistake on their end.No further information provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; returned to manufacturer on: 6/10/2021; section h3: device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed, that the lens had a detached haptic.Which can be attributed to handling.And cannot be confirmed, to be related to manufacturing.The lens was cleaned, and no additional cosmetic defects were observed.Measuring image quality (miq) report, per device history record, indicates 23.87 diopter size.The complaint issue could not be confirmed.And no product deficiency could be identified.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11879384
• Report Number: 9614546-2021-07174
• Device Sequence Number: 16396222
• Product Code: HQL
• UDI-Device Identifier: 05050474659056
• UDI-Public: (01)05050474659056(17)250707
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2025
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR